Customer Notice

  • U.S. URGENT FIELD CORRECTION Notification Regarding Correction to Endoscope Suction Arm for PENTAX Medical Video Bronchoscopes, Ultrasound Bronchoscopes, and Video Nasopharyngolaryngoscopes

    May 23, 2017

    Dear Valued Customer,

    The purpose of this communication is to inform you that PENTAX Medical has become aware that the screw connecting the suction arm to the control body on some of its legacy endoscopes may loosen with time.  A loose suction arm may result in inadequate suctioning due to leakage of air.  There is also the potential for organic debris to accumulate in the space between the suction nipple and control body.  In some cases, these events could potentially cause cross-contamination between patients.

    Identification of Affected Products

    Table 1 provides a list of the affected products.  Please note that while this field action affects legacy endoscopes, endoscopes manufactured by PENTAX Medical after January 26, 2011 have a corrected design, and are NOT subject to this field action.

    Model Number

    Product Name

    Endoscopes Affected

    EB-1170K

    Video Bronchoscope

    Purchased from 10/25/2006 – January 26, 2011

    EB-1570

    Video Bronchoscope

    Purchased from 8/23/2003 – January 26, 2011

    EB-1570AK Video Bronchoscope Purchased from 3/30/2009 – January 26, 2011
    EB-1570K Video Bronchoscope Purchased from 10/24/2002 – January 26, 2011
    EB-1970AK Video Bronchoscope Purchased from 4/23/2007 – January 26, 2011
    EB-1970K Video Bronchoscope Purchased from 10/24/2002 – January 26, 2011
    EB-1970TK Video Bronchoscope Purchased from 12/3/2008 – January 26, 2011
    EB-1970UK Video Bronchoscope Purchased from 1/14/2009 – January 26, 2011
    VNL-1570STK Video Nasopharyngolaryngoscope          Purchased from 4/26/2007 – January 26, 2011

    Customer Instructions:

    Enclosed with this letter is a field correction response form. The form identifies the affected endoscopes which have been sold to your facility.  Please forward this letter and the enclosures to the department in which the above referenced items are in use.  It is suggested that the end user of the affected products completes this form and returns it to PENTAX Medical.

    Check if the affected products in Table 1 are in use at your facility.  Record on the customer response form whether the affected products are still owned by your facility.  If a customer indicates that they own an endoscope affected by this field action, PENTAX Medical will contact them to have the product repaired.    

    Contact Information

    If you have any questions regarding this action, please feel free to contact PENTAX Medical Customer Service.

    Tel:         800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)    

    Fax:        201-799-4063 (alternate 201-391-4189)

    Email:    customeradvisories@pentaxmedical.com

    This field correction is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,

    PENTAX of America Inc.
    Department of Quality Assurance & Regulatory Affairs

    Supplementary Documents

    Suction Arm Customer Response Form

    Suction Arm FSCA Letter

  • U.S. URGENT RECALL LETTER Video Cystoscope Product Removal - For United States Customers Only

    July 12, 2017

    Dear Valued Customer,

    The Video Cystoscopes (ECY-1570 and ECY-1570K) have been discontinued and are no longer available for sale in the US. The ECY-1570 and the ECY-1570K were launched by PENTAX Medical in the US market in 2006. These video cystoscopes are used for detailed visualization of tissue structures in day-to-day urology. This recall has been initiated due to an outdated regulatory clearance. Use of this product will not likely cause any adverse events.

    PENTAX Medical has discontinued the sale and support of these endoscopes and to withdraw them from the US market. The products were released under a letter to file. PENTAX Medical has made a business decision not to make a 510(k) submission. These devices will continue to be sold and supported outside of the US. This change is effective immediately.

    Customers who acknowledge on the attached customer response form that they still own the models in question will be contacted by their PENTAX Territory Manager.

    Affected Product Details:

    Product: Ultrasound Video Gastroscope Models EG-3670URK and EG-3870UTK

    Instructions for Use: Z845 Revisions 13 and 14 (R13 and R14)

    Customer Instructions:

    Customers should inspect their stock of PENTAX Medical ECY-1570 and ECY-1570K video cystoscopes, quarantine them, and discontinue use of these products.  If you have sold and distributed these products, please provide a copy of the notice and response form to the new owners.

    Enclosed with this letter is a customer response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility. The attached form should be completed and returned to PENTAX Medical.

    Contact Information

    If you have any questions regarding this action, please feel free to contact PENTAX Medical Customer Service.

    Tel:         800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)    

    Fax:        201-799-4063 (alternate 201-391-4189)

    Email:    customeradvisories@pentaxmedical.com

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,

    PENTAX of America Inc.
    Department of Quality Assurance and Regulatory Affairs

    Supplementary Documents

    Video Cystoscope Customer Response Form

    Video Cystoscope FSCA Letter

  • U.S. URGENT FIELD CORRECTION Notification of Update to Instructions for Use (IFU) Ultrasound Video Gastroscope Models EG-3670URK and EG-3870UTK

    May 23, 2017

    Dear Valued Customer,

    PENTAX Medical has become aware of an error in the Instructions for Use (IFU) for ultrasound video gastroscope models EG-3670URK and EG-3870UTK.  Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions.

    Affected Product Details:

    Product: Ultrasound Video Gastroscope Models EG-3670URK and EG-3870UTK

    Instructions for Use: Z845 Revisions 13 and 14 (R13 and R14)

    Safety Instructions:

    Although no incidents related to this error have been reported to PENTAX Medical, please be informed about the following error and correction:

    Table 1:

    Page

    Error

    Correct

    p70

    WARNING:

    The cleaning detergent solution should remain in contact with the ALL internal channels and external endoscope surfaces for the time period recommended by the manufacturer of the disinfectant.

    WARNING:

    The disinfecting solution must remain in contact with the ALL internal channels and external endoscope surfaces for the time period recommended by the manufacturer of the disinfectant.

    Customer Instructions:

    In order to ensure the proper use and cleaning of the affected PENTAX endoscopes, please have users read and carefully follow the IFU addendum that is included with this letter.  If a new IFU is needed, please visit PENTAX Medical’s IFU portal (https://ifu.pentaxmedical.com/welcome-to-pentax-medical/). We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Also enclosed with this letter is a field correction response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility.  Please forward this letter and the enclosures to the department in which the above referenced items are in use.  The end user of the affected products should complete this form and return it to PENTAX Medical.

    Contact Information

    If you have any questions regarding this action, please feel free to contact PENTAX Medical Customer Service.

    Tel:         800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)    

    Fax:        201-799-4063 (alternate 201-391-4189)

    Email:    customeradvisories@pentaxmedical.com

    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,
    PENTAX of America Inc.
    Director of Regulatory Affairs

    Enclosures:

    Customer Response Form, Control Number MK-951                                      
    Ultrasound Gastroscope IFU (Z845) Addendum, MK-958 Rev. A

    For a PDF copy of this Urgent Field Correction letter, please click here.

    Supplementary Documents

    Field Correction Response Form (MK-951)

    IFU Addendum Z845 R3 and R14 

  • U.S. URGENT FIELD CORRECTION 16-006 Updated Instructions for Use for PENTAX Medical ED-3490TK Video Duodenoscope

    February 19, 2016

    Dear Valued Customer,

    The purpose of this communication is to inform you that PENTAX Medical is issuing an updated Reprocessing Instructions for Use (IFU) [S041_R00] and Operation IFU [Z933_R06] for the PENTAX Medical ED-3490TK Video Duodenoscope. The Reprocessing IFU  includes updated validated procedures for cleaning, high level disinfection, and sterilization. The Operation IFU provides instruction to the user for the detection and resolution of a clogged channel and ensures consistent reference to the Reprocessing IFU for direction regarding the cleaning, high level disinfection and sterilization of the ED-3490TK. Both sets of instructions should be implemented as soon as possible. For your convenience paper copies of the Reprocessing and Operation IFUs are enclosed with this letter.

    This action is being taken as a result of publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatography (ECRP) procedures. Given these reports, and in an abundance of caution, PENTAX Medical has been working with the U.S. Food and Drug Administration (“FDA”) to validate the reprocessing procedures that are provided in the updated Reprocessing IFU.

    Revised Instructions

    The updated PENTAX Medical ED-3490TK Reprocessing Instructions for Use include additional text, figures, cautions, and warnings that are intended to clarify and reflect the newly validated manual cleaning, high level disinfection and liquid chemical sterilization procedures. The following is an overview of some of the main changes in the updated Reprocessing IFU:

    • Pre-cleaning:
      • Additional detail regarding flushing of the elevator mechanism with detergent
    • Manual Cleaning:
      • Additional detail regarding detergent solution preparation and use
      • New steps detailing brushing with existing PENTAX Medical cleaning brushes (CS-C9S and CS6021T) and flushing of the elevator mechanism
      • Increased volumes of fluids for internal channels
      • Additional detail regarding brushing of the instrument channel inlet
      • Increased number of endoscope rinses after detergent immersion
      • Additional warning regarding the potential for instrument channel obstruction
    • Manual High Level Disinfection (HLD):
      • Additional detail regarding high level disinfectant preparation and use
      • Additional detail regarding flushing of the elevator mechanism during HLD
      • Increased volumes of fluids for internal channels
      • Increased number of endoscope rinses after disinfectant immersion
    • Sterilization:
      • Removal of ethylene oxide as a sterilization method
      • Addition of STERIS System 1E® as a liquid chemical sterilization method

    The following is an overview of some of the main changes in the updated PENTAX Medical ED-3490TK Operation IFU:

    • Changed the term “reprocessing/maintenance manual” to “Instructions for Use (Reprocessing)” throughout the IFU
    • Changed the Front Cover reference to the Reprocessing IFU for Cleaning, High Level Disinfection, and Sterilization Instructions
    • Added warning regarding the potential for instrument channel obstruction
    • Removed the summary of the reprocessing method in Section 4.0 Care After Use, and instructed reader to reference the Reprocessing IFU

    Instructions Regarding Prior Versions of the Reprocessing and Operation Instructions for Use

    Please ensure that user departments discard prior versions of the Reprocessing IFU (Z863) and Operation IFU (Z933). Users must read and follow these instructions in order to properly operate and reprocess the PENTAX Medical ED-3490TK Video Duodenoscope. Please check with your facility’s applicable supply departments to determine if you have any copies of the prior versions of the IFUs and replace the existing versions with those enclosed.

    PENTAX Medical has a dedicated team of clinical specialists who visit customer facilities and perform reprocessing in-servicing and training. Please contact your PENTAX Medical sales representative at your earliest convenience to arrange for training regarding these new procedures. Customers are also invited to register to the PENTAX Medical Patient First website (http://patientfirst.pentaxmedical.com) to gain access to the latest revision of these and all other current-generation PENTAX Medical endoscope IFUs in digital format.

    Response Form

    Enclosed with this letter is a Field Correction Response Form. The form identifies all PENTAX Medical ED-3490TK Video Duodenoscopes that have been consigned (sold, loaned, or leased) to your facility. Please forward this letter and the enclosures to the relevant department in your facility so that they may review the information provided and complete the response form. Please note that you must return the completed form even if you do not have any IFUs to discard. Your local sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information required by FDA.

    Contact Information

    If you have any questions regarding this action, please feel free to contact Paul Silva, PENTAX Americas Recall Coordinator at:

    Tel: 800-431-5880 ext. 2064 (8:30 AM – 5:00 PM, Monday – Friday, EST)      

    Fax: 201-799-4063

    Email: recall.coordinator@pentaxmedical.com


    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    Affected Serial Numbers
    ED-3490TK

    A110021, A110022, A110023, A110024, A110025, A110026, A110027, A110028, A110029, A110030, A110031,

    A110032, A110033, A110034, A110035, A110036, A110037, A110038, A110039, A110043, A110046, A110051,

    A110055, A110056, A110057, A110058, A110059, A110060, A110061, A110062, A110063, A110064, A110065,

    A110067, A110068, A110070, A110071, A110072, A110073, A110074, A110075, A110076, A110077, A110078,

    A110079, A110080, A110081, A110082, A110083, A110086, A110087, A110088, A110089, A110090, A110091,

    A110092, A110095, A110098, A110099, A110100, A110114, A110115, A110116, A110117, A110118, A110121,

    A110122, A110127, A110128, A110129, A110130, A110131, A110132, A110133, A110134, A110135, A110136,

    A110137, A110138, A110140, A110142, A110143, A110150, A110152, A110156, A110157, A110158, A110159,

    A110160, A110162, A110163, A110164, A110165, A110166, A110167, A110168, A110169, A110170, A110173,

    A110174, A110177, A110178, A110179, A110180, A110182, A110183, A110190, A110191, A110192, A110193,

    A110194, A110203, A110204, A110206, A110207, A110208, A110209, A110210, A110211, A110213, A110214,

    A110215, A110216, A110217, A110218, A110229, A110230, A110231, A110232, A110233, A110234, A110235,

    A110236, A110237, A110243, A110244, A110246, A110247, A110248, A110249, A110250, A110251, A110252,

    A110258, A110259, A110260, A110268, A110269, A110272, A110273, A110274, A110275, A110276, A110277,

    A110278, A110279, A110280, A110281, A110283, A110284, A110285, A110287, A110288, A110289, A110290,

    A110293, A110297, A110301, A110302, A110304, A110305, A110306, A110307, A110308, A110316, A110317,

    A110318, A110319, A110320, A110321, A110322, A110323, A110324, A110325, A110326, A110327, A110328,

    A110329, A110331, A110333, A110338, A110339, A110345, A110347, A110352, A110362, A110363, A110385,

    A110386, A110387, A110388, A110389, A110390, A110391, A110392, A110393, A110399, A110403, A110405,

    A110406, A110407, A110409, A110410, A110412, A110413, A110415, A110416, A110417, A110418, A110419,

    A110421, A110422, A110424, A110438, A110439, A110440, A110454, A110462, A110464, A110466, A110468,

    A110470, A110473, A110474, A110476, A110480, A110483, A110491, A110492, A110495, A110496, A110497,

    A110498, A110499, A110501, A110502, A110518, A110520, A110521, A110524, A110525, A110527, A110534,

    A110535, A110538, A110547, A110549, A110550, A110553, A110554, A110555, A110574, A110581, A110582,

    A110587, A110588, A110589, A110590, A110591, A110593, A110594, A110595, A110596, A110598, A110599,

    A110600, A110601, A110602, A110607, A110610, A110612, A110614, A110615, A110616, A110617, A110619,

    A110620, A110621, A110623, A110625, A110626, A110633, A110649, A110651, A110652, A110654, A110665,

    A110666, A110667, A110668, A110669, A110670, A110671, A110672, A110674, A110675, A110676, A110677,

    A110678, A110680, A110682, A110683, A110684, A110686, A110692, A110694, A110695, H110699, H110700,

    H110701, H110703, H110704, H110705, H110706, H110707, H110708, H110709, H110710, H110711, H110712,

    H110714, H110715, H110716, H110717, H110718, H110719, H110721, H110723, H110729, H110733, H110736,

    H110737, H110738, H110740, H110749, H110754, H110767, H110773, H110774, H110775, H110779, H110780,

    H110781, H110782, H110783, H110784, H110786, H110788, H110789, H110790, H110791, H110792, H110793,

    H110794, H110795, H110796, H110797, H110799, H110800, H110802, H110803, H110805, H110807, H110819,

    H110822, H110823, H110825, H110826, H110827, H110828, H110830, H110831, H110832, H110834, H110835,

    H110837, H110838, H110840, H110842, H110844, H110845, H110846, H110849, H110850, H110851, H110852,

    H110853, H110858, H110859, H110860, H110861, H110862, H110863, H110865, H110866, H110867, H110868,

    H110869, H110870, H110871, H110872, H110873, H110876, H110877, H110880, H110881, H110882, H110883,

    H110890, H110891, H110892, H110893, H110894

    For a PDF copy of this Urgent Field Correction letter, please click here

    To view the FDA Safety Communication, please visit the following link, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm486772.htm.

  • U.S. URGENT FIELD CORRECTION 17-001.2 PENTAX Medical ED-3270K Video Duodenoscope

    January 15, 2017

    Dear Healthcare Professional,

    In February 2016 we communicated to you and our other customers that PENTAX Medical (“PENTAX”) retired service and support for PENTAX 30, 40, and 70 series duodenoscopes. These duodenoscope models were introduced into the market over ten years ago and have since been replaced with the current generation model, ED-3490TK Video Duodenoscope.

    In August 2016 we contacted your facility to offer to exchange the ED-3490TK at no cost for any retired Pentax 30, 40, or 70 series duodenoscope that is currently owned and actively used. We understand that your facility has decided not to transition its ED-3270K duodenoscope for the ED-3490TK notwithstanding our decision not to conduct additional validation testing on the reprocessing instructions because of an expressed medical preference for use of the small diameter scope for pediatric patients and those with difficult anatomy. 

    By this letter, we are writing to inform you about a potential issue associated with the distal cap of the ED-3490TK, which we believe could also impact the ED-3270K, and offer recommendations intended to reduce the potential risk for contamination and subsequent patient infection. During manufacturing, silicone adhesive is applied to the distal tip prior to affixing the distal cap. In some instances, cracks or gaps may form in the adhesive that may be vulnerable to fluid ingress and soiling. 

    PENTAX is working closely with the FDA to further evaluate and mitigate the potential risk of infection associated with leakage, if leakage were to occur, into or out of the distal cap area.

    Action Steps:

    PENTAX reminds its customers of the importance of following product labeling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the Instructions for Use for manual reprocessing of these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required. 
    Additionally, PENTAX recommends that you immediately remove from use any ED-3270K duodenoscope that shows visible signs of wear or physical damage. Continuing to use devices with integrity issues (i.e. holes, cracks, kinks and scratches) can contribute to persistent device contamination and subsequent patient infection. PENTAX will replace any ED-3270K duodenoscopes with visible signs of wear or physical damage with its current generation model, the ED-3490TK Video Duodenoscope. 

    PENTAX regrets any inconvenience and encourages any facility or institution with questions or requests for further information or assistance regarding this Communication to contact PENTAX Medical Customer Support at 1-800-431-5880.

    Adverse events or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program and to PENTAX as soon as possible at vigilance@pentaxmedical.com

    If you have any questions regarding this action, please feel free to contact us at:
    Tel: 1-800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST) 
    Fax: 201-799-4063 (alternate 201-391-4189) 
    Email: customeradvisories@pentaxmedical.com 

    PENTAX will issue additional communications as further information becomes available. Please be assured that maintaining patient safety and quality is our utmost priority. 

    Sincerely,

    PENTAX of America, Inc.

  • U.S. URGENT FIELD CORRECTION 16-016 Revised Instructions for Use of PENTAX Medical Rigid Laryngostroboscopes Models 9106 and 9108

    December 12, 2016

    Dear Valued Customer,

    The purpose of this communication is to inform you that PENTAX Medical is issuing a new instructions for use (IFU) for two rigid laryngostroboscopes models – 9106 and 9108. This new IFU clarifies the reprocessing instructions in order to ensure that customers are aware of the best methods for cleaning their 9106 and 9108 laryngostroboscopes. Formerly, the reprocessing instructions for these endoscopes were included within the operator manual for the PENTAX Medical Stroboscopy System or 9310HD Recording Module.

    Identification of Affected Endoscope Models

    Table 1 provides an overview of the historical and revised IFUs containing instructions for 9106 and 9108 laryngostroboscopes.

    Instructions Regarding IFUs
    Please ensure that all users read and carefully follow the revised IFU in order to properly operate and reprocess the affected PENTAX endoscopes. The reprocessing instructions in the revised IFU supersede those the above referenced operator manuals. We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Response Form
    Enclosed with this letter is a field correction response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility. Please forward this letter and the enclosures to the department in which the above referenced items are in use. It is suggested that the end user of the affected endoscopes complete this form and return it to PENTAX.

    Please be aware that you must return the completed form even if you no longer possess these PENTAX endoscopes. Your local sales representative can assist you in completing this form. This information is essential in order to maintain field correction effectiveness information required by law.

    Contact Information
    If you have any questions regarding this action, please feel free to contact us at:
    Tel:         800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax:        201-799-4063 (alternate 201-391-4189)
    Email:   customeradvisories@pentaxmedical.com
    This field correction is being made with the knowledge of the U.S. Food and Drug Administration.
    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,

    PENTAX of America Inc.
    Department of Quality Assurance & Regulatory Affairs

    Supplementary Documents
    Field Correction Response Form (F04-REG-0001415)
    Rigid Scope IFU D04-IFU-0001400 Rev. B
    Rigid Scope FSCA Letter (MK-869)

  • U.S. URGENT FIELD CORRECTION 16-015 Revised Operation and Reprocessing Instructions for Use of PENTAX Medical Video Nasopharyngolaryngoscopes Models VNL-1190STK and VNL-1590STI

    September 21, 2016

    Dear Valued Customer,

    The purpose of this communication is to inform you that PENTAX Medical is issuing a new combined operation and reprocessing instructions for use (IFU) for three diagnostic video-nasopharyngolaryngoscope models – VNL-1070STK, VNL-1190STK, and VNL-1590STI.  This new combined IFU reflects changes to the scopes’ intended use, model name and number, and sterilization method as well as additional clarifying detail to the operation and reprocessing instructions.  

    Revised Labeling and Instructions

    The following is an overview of the main changes to the labeling and IFU:

    • Removed all references to video-nasopharyngolaryngoscopes or VNL models and replaced them with video laryngostroboscopes or VLS models.
    • Updated the intended use statement. The revised IFU clarifies that the scopes are intended to provide optical visualization (via video monitor) of the laryngeal and pharyngeal area in order to observe glottic action with the use of a stroboscopic light source. These instruments are introduced via the mouth or the nose, as decided by physician, when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
    • Added references to EPK-i5010, and removed references to EPK-p to reflect changes to the portfolio of processors currently used in the United States.
    • Updated the sterilization section to refer to Steris System 1E Liquid Chemical Sterilant.
    • Removed references to endoscopes not covered by this change.
    • Updated to add additional detail to the cleaning instructions, cleaning agents, and high level disinfectants.

    Identification of Affected Endoscope Models
    Table 1 provides an overview of the Affected Endoscope models, the new model numbers, and the document number and revision number for the historical and revised IFUs. The accompanying USB flash drive contains the revised IFU identified below. Please distribute only those IFUs which support the products owned by your facility. If there are any technical challenges with accessing the IFU on the flash drive, a copy of the file is available on the PENTAX Medical website at https://pentaxmedical.com/pentax/en/99/1/News.

     

    Instructions Regarding Historical IFUs
    Please ensure that user departments discard the prior versions of these Instructions for Use and that all users read and carefully follow the Revised IFU in order to properly operate and reprocess the affected PENTAX endoscopes. We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Response Form
    Enclosed with this letter is a Field Correction Response Form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility.  Please forward this letter and the enclosures to the department in which the above referenced items are in use.  It is suggested that the end user of the affected endoscopes complete this form and return it to PENTAX.

    Please be aware that you must return the completed form even if you no longer possess PENTAX endoscopes.  Your local sales representative can assist you in completing this form. This information is essential in order to maintain field correction effectiveness information required by law.

    Contact Information

    If you have any questions regarding this action, please feel free to contact us at:

    Tel:       800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax:      201-799-4063 (alternate 201-391-4189)
    Email:   recall.coordinator@pentaxmedical.com

    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    To download a PDF copy of this Urgent Field Correction, please click here.

    Supplementary Documents
    Field Correction Response Form (F04-REG-0001415)
    Video Laryngostroboscopes Operation & Reprocessing IFU (S118 R00)
    VLS Product Labeling Change Notice (MK-862)

     

  • U.S. URGENT FIELD CORRECTION16-009/010 Revised Instructions for Use of PENTAX EB-1970UK, EB-70K, and 75K Series Video Bronchoscopes

    May 31, 2016

    Dear Valued Customer,

    In April 2014, PENTAX Medical received clearances from the FDA for modifications to the Operation and Reprocessing Instructions for Use (IFU) for the 70K and 75K series of video bronchoscopes and the EB-1970UK ultrasound video bronchoscope (“Affected Endoscopes”). These revised instructions have not been included in product shipments since the time of these clearances. PENTAX Medical is initiating this field action to provide customers that have purchased the Affected Endoscopes with the most recent Operation and Reprocessing IFUs. For your convenience, a USB flash drive containing electronic copies of the Operation and Reprocessing IFUs and accompanying addenda for the Affected Endoscopes is provided with this letter. These revised Operation and Reprocessing instructions should be implemented as soon as possible.

    Revised Instructions
    The instructions have been revised in the following manner:

    • Operation IFU
      • Integrated all models of each family into the IFU
      • Modified the indications for use language to be consistent with similar products
      • Enhanced the explanation of the operation of the device
      • Revised and added cautions and warnings
    • Reprocessing IFU
      • Included more specificity regarding reprocessing activities to aid in the proper method for reprocessing the endoscopes, including:
        • number of brush and rinse steps
        • quantity of fluid volumes
        • use of additional text, figures, cautions, and warnings

    Identification of Affected Endoscope Models
    Table 1 provides an overview of the Affected Endoscope models, and the part number and revision of the historical and revised IFUs. The accompanying USB flash drive contains all the revised IFUs identified below. Please distribute only those IFUs which support the products owned by your facility.

    Table 1 - FSCA for EB and EBUS Scopes

    Instructions Regarding Historical IFUs
    Please ensure that user departments discard the prior versions of these Instructions for Use and ensure that all users read and carefully follow the revised Operation and Reprocessing IFUs to ensure the proper use and cleaning of the affected PENTAX endoscopes. We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Response Form
    Enclosed with this letter is a Field Correction Response Form. The form identifies the Affected Endoscopes (Model and Serial Number) which have been consigned (sold, loaned, or leased) to your facility. Please forward this letter and the enclosures to the relevant department in your facility so that they may review the information provided and complete the response form. Please note that you must return the completed form even if you do not have any IFUs to discard. Your local sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information required by FDA.

    Contact Information
    If you have any questions regarding this action, please feel free to contact Paul Silva, PENTAX Americas Recall Coordinator at:

    Tel:       800-431-5880 ext. 2064 (8:30 AM – 5:00 PM, Monday – Friday, EST) 

    Fax:      201-799-4063 (alternate 201-391-4189)

    Email:    recall.coordinator@pentaxmedical.com

    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    To download a PDF copy of this Urgent Field Correction, please click here.

    Supplementary Documents
    Field Correction Response Form (F04-FLD-0001330 R00)

    Video Bronchoscopes Operation IFU (S015_R04)
    Video Bronchoscopes Reprocessing IFU (S020_R04)

    Ultrasound Video Bronchoscopes Operation IFU (S016_R02)
    Ultrasound Video Bronchoscopes Reprocessing IFU (S021_R04)

    IFU Addendum 388_R01
    IFU Addendum 392_R00

  • U.S. URGENT FIELD CORRECTION 16-007 Use of Disposable Water Bottle Assembly and Instructions for Use Addendum for PENTAX Video Processor & Endoscopes with Air/Water Channels

    April 7, 2016

    Dear Valued Customer,

    PENTAX Medical video processors and light sources are utilized with a disposable water bottle assembly comprised of a tubing adaptor and sterile water bottle that is intended to provide water and air for the cleaning of the objective lens of PENTAX Medical endoscopes. It has come to our attention that the PENTAX Medical Video Processor EPK-i5010 has been shipped with a reusable PENTAX Medical water bottle assembly (OS-H4) which has not been cleared for use with the EPK-i5010 in the United States. As a result, all customers that have previously received an OS-H4 water bottle with an EPK-i5010 for use with an endoscope with an air/water channel should discard these bottles and should use the PENTAX Medical DispoCap Air Tubing in their place. Users of other PENTAX Medical video processors and light sources should also discard their reusable PENTAX water bottle assemblies (OS-H2 & OS-H4) and replace them with the PENTAX Medical DispoCap Air Tubing. In addition, PENTAX Medical is issuing an Addendum to the Operation and Reprocessing Instructions for Use (IFU) for certain models of endoscopes to remove non-applicable steps as they relate to the water bottle assembly in the pre-cleaning of the endoscope in the procedure room.

    The pre-cleaning steps in these Operation and Reprocessing IFUs include an instruction to turn the lever on the water bottle to the ‘drain’ position in order to empty the water channel, however, this action is unique to the reusable PENTAX Medical water bottle and is not relevant for a disposable water bottle assembly. As a result, PENTAX Medical is issuing the attached IFU Addendum which instructs customers to disregard this step. The pre-cleaning instructions are otherwise accurate and complete as it pertains to the disposable water bottle assembly. This addendum should be placed in the Operation and Reprocessing IFUs originally provided with the endoscope at the time of purchase. Please ensure that user departments discard any PENTAX OS-H2/OS-H4 water bottles and transition to the PENTAX Medical DispoCap Air Tubing (Model 100160P) for use with a disposable sterile water bottle.

    Contact Information

    If you have any questions regarding this action, please feel free to contact Paul Silva, PENTAX Americas Recall Coordinator at:

    Tel: 800-431-5880 ext. 2064 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax: 201-799-4063
    Email: recall.coordinator@pentaxmedical.com

    Please contact PENTAX Medical customer service to place orders for the PENTAX Medical DispoCap Air Tubing, Model 100160P.

    Tel: 800-431-5880; Email: salessupport2@pentaxmedical.com

    This correction is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Affected Products

    The following PENTAX Endoscopes with air/water channels (all serial numbers) which utilize PENTAX Video Processors and Light Sources (EPK-i5010, EPK-1000, EPK-i and LH-150-PC) with PENTAX Reusable Water Bottles.

    PENTAX Video Colonoscopes:
    EC-2990LI, EC-3430L, EC-3430LK, EC-3440L, EC-3470LK, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-380LKP, EC-3830LK, EC-3830LZ, EC-3830TLK, EC-3831L, EC-3832L, EC-3832LK, EC-3832TL, EC-3840L, EC-3870CILK, EC-3870LK, EC-3870LZK, EC-3870TLK, EC-3872LK, EC-3872TLK, EC-3890LI, EC-3890LK, EC-3890TLK, and EC38-I10L

    PENTAX Video Gastroscopes:
    EG-1540, EG-1580K, EG-1690K, EG-1840, EG-1870K, EG-2470K, EG-2490K, EG-2530, EG-2540, EG-2730K, EG-2731, EG-2770K, EG-2790I, EG-2790K, EG27-I10, EG-290KP, EG-2930K, EG-2931,EG-2931K, EG-2940, EG-2970K, EG-2990I, EG-2990K, EG29-I10, EG-3430Z, EG-3470K, EG-3470ZK, EG-3490K, EG-3831T, EG-3840T, EG-3870CIK, EG-3870TK, EG-3870UTK, and EG-3890TK

    PENTAX Transnasal Endoscopes:
    EE-1540, EE-1580K

    PENTAX Video Duodenoscope:
    ED-3490TK

    PENTAX Video Ultrasound Gastroscopes:
    EG-3630U, EG-3630UR, EG-3670URK, and EG-3830UT

    PENTAX Video Sigmoidoscopes:
    ES-3831, ES-3840, and ES-3870K

    PENTAX Fiber Endoscopes:
    FC-38LV, FD-34V, FG-16V, FG-24V, FG-29V, FG-34UX, FG-36UX, FG-38UX, and FS-34V

    PENTAX Small Bowel Enteroscopes:
    VSB-3430K

    For a PDF copy of this Urgent Field Correction letter, please click here

    Supplementary Documents
    Reprocessing IFU Addendum, Control Number D04-IFU-0001206, Rev. A
    Medical Device Recall Response Form, Control Number F04-FLD-0001198, Rev. A

     

     

     

  • U.S. URGENT FIELD CORRECTION 16-008 Instructions for Use Addendum for Endoscopes with Instrument Channels

    April 7, 2016

    Dear Valued Customer,

    PENTAX Medical has become aware that operational/cleaning accessories and therapeutic devices can become lodged in an endoscope’s instrument channel. If not detected, the blocked instrument channel can result in ineffective reprocessing and/or the introduction of debris and/or device components into a patient during a subsequent procedure, posing a risk of cross-contamination. As a result, PENTAX Medical is issuing Addendum 388 R01 to the Operation and Reprocessing Instructions for Use (IFU) for all models of endoscopes with instrument/suction channels.

    The purpose of the Addendum is to remind customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope’s instrument/suction channel and to ensure that any therapeutic devices (e.g., clips, stents, balloons, etc.) passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. In such a case, contact your local PENTAX Medical service facility to have the endoscope repaired.

    Contact Information
    If you have any questions regarding this action, please feel free to contact Paul Silva, PENTAX Americas Recall Coordinator at:

    Tel: 800-431-5880 ext. 2064 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax: 201-799-4063
    Email: recall.coordinator@pentaxmedical.com

    This correction is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Affected Products
    Endoscopes with Instrument Channels (all serial numbers):

    PENTAX Video Bronchoscopes:
    EB-1170K, EB-1530T3, EB-1570K, EB-1575K, EB-1830T3, EB-1970K, EB-1970TK, EB-1970UK, and EB-1975K

    PENTAX Video Colonoscopes:
    EC-2990LI, EC-3430L, EC-3430LK, EC-3440L, EC-3470LK, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-380LKP, EC-3830LK, EC-3830LZ, EC-3830TLK, EC-3831L, EC-3832L,EC-3832LK, EC-3832TL, EC-3840L, EC-3870CILK, EC-3870LK, EC-3870LZK, EC-3870TLK, EC-3872LK, EC-3872TLK, EC-3890LI, EC-3890LK, EC-3890TLK, and EC38-I10L

    PENTAX Video Gastroscopes:
    EG-1540, EG-1580K, EG-1690K, EG-1840, EG-1870K, EG-2470K, EG-2490K, EG-2530, EG-2540, EG-2730K, EG-2731, EG-2770K,EG-2790I, EG-2790K, EG27-I10, EG-290KP, EG-2930K, EG-2931,EG-2931K, EG-2940, EG-2970K, EG-2990I, EG-2990K, EG29-I10, EG-3430Z, EG-3470K, EG-3470ZK, EG-3490K, EG-3831T, EG-3840T, EG-3870CIK, EG-3870TK, and EG-3890TK

    PENTAX Transnasal Endoscopes:
    EE-1540, EE-1580K

    PENTAX Video Ultrasound Gastroscopes:
    EG-3630U, EG-3630UR, EG-3670URK, EG-3830UT, and EG-3870UTK

    PENTAX Video Sigmoidoscopes:
    ES-3831, ES-3840, and ES-3870K

    PENTAX Fiber Endoscopes:
    FC-38LV, FD-34V, FG-16V, FG-24V, FG-29V, FG-34UX, FG-36UX, FG-38UX, and FS-34V

    PENTAX Small Bowel Enteroscopes:
    VSB-3430K

    PENTAX Video Nasolaryngeal Endoscopes:
    VNL-1530T and VNL-1570STK

    PENTAX Choledochoscopes:
    FCP-8P and FCP-9P

    PENTAX Fiber and Video Choledoco-Nephroscopes:
    FCN-15X and ECN-1530

    PENTAX Fiber and Video Cystoscopes:
    FCY-15P2, FCY-15RBS, ECY-1530, and ECY-1570K

    PENTAX Fiber Bronchoscopes:
    FB-10V, FB-15BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, and FB-8V

    PENTAX Fiber Intubation Endoscopes:
    FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS, and FI-9RBS

    PENTAX Fiber Nasolaryngeal Endoscopes:
    FNL-10RAP, FNL-13RAP, and FNL-15RP3

    PENTAX Fiber Ureteroscopes:
    FUR-9P and FUR-9RBS

    To download a PDF copy of this Urgent Field Correction, please click here.

  • U.S. URGENT FIELD CORRECTION 16-011/012 Revised Operations and Reprocessing Instructions for Use of PENTAX 90-series Video Colonoscopes and 90-Series Video Gastroscopes

    August 15, 2016

    Dear Valued Customer,

    In April 2014, PENTAX Medical received clearances from the FDA for modifications to the Operation and Reprocessing Instructions for Use (IFU) for the 90-series of video colonoscopes and video gastroscopes (“Affected Endoscopes”). These revised instructions have not been included in product shipments since the time of these clearances.

    PENTAX Medical is initiating this field action to provide customers that have purchased the Affected Endoscopes with the most recent Operation and Reprocessing IFUs. For your convenience, a USB flash drive is provided containing electronic copies of the Operation and Reprocessing IFUs and accompanying addenda and bulletins. These revised instructions should be implemented as soon as possible.

    Some of the video colonoscope and video gastroscope models (see Table 2 below) have a forward water jet channel that requires an OE-C20 cleaning adapter.  Customers who need OE-C20 adapters can purchase them from PENTAX Medical for affected endoscope models by requesting part number KUM-OEC20-FCA.

    Revised Instructions
    The instructions have been revised in the following manner:

    • Operation IFU
      • Integrated all models of each family into the IFU
      • Modified the indications for use language to be consistent with similar products
      • Enhanced the explanation of the operation of the device
      • Revised and added cautions and warnings
    • Reprocessing IFU
      • Included more specificity regarding reprocessing activities to aid in the proper method for reprocessing the endoscopes, including:
        • number of brush and rinse steps,
        • quantity of fluid volumes,
        • use of additional text, figures, cautions, and warnings
      • Integrated use of OE-C20 adaptor

    Identification of Affected Endoscope Models
    Table 1 provides an overview of the Affected Endoscope models, and the part number and revision of the historical and revised IFUs. The accompanying USB flash drive contains all the revised IFUs identified below. Please distribute only those IFUs which support the products owned by your facility.

    EC and EG Video Scopes FSCA Table 1

    Instructions Regarding Historical IFUs
    Please ensure that user departments discard the prior versions of these Instructions for Use and ensure that all users read and carefully follow the revised Operation and Reprocessing IFUs to ensure the proper use and cleaning of the affected PENTAX endoscopes. We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Need for OE-C20 Cleaning Adapter
    Table 2 is a chart of each 90-series video colonoscope and video gastroscope model, and whether that model has a forward water jet that requires an OE-C20 cleaning adapter.  

    EC and EG Video Scopes FSCA Table 2

    Response Form
    Enclosed with this letter is a Field Correction Response Form. The form identifies the Affected Endoscopes (Model and Serial Number) which have been sold to your facility. Please forward this letter and the enclosures to the relevant department in your facility so that they may review the information provided and complete the response form. Please note that you must return the completed form even if you do not have any IFUs to discard. Your local sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information required by FDA.

    Contact Information
    If you have any questions regarding this action, please feel free to contact Paul Silva, PENTAX Americas Recall Coordinator at:
    Tel:       800-431-5880 ext. 2064 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax:      201-799-4063 (alternate 201-391-4189)
    Email:   recall.coordinator@pentaxmedical.com

    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    To download a PDF copy of this Urgent Field Correction, please click here.

    Supplementary Documents
    Field Correction Response Form (F04-REG-0001384 R00)

    IFU Addendum: Correction to Operation & Pre-Cleaning Instructions for Endoscopes with Air/Water Channels (D04-IFU-0001206 Rev A)
    IFU Addendum (388_R01)
    IFU Addendum (392_R00)

    Video Colonoscopes Operation IFU (S017_R01)
    Video Colonoscopes Reprocessing IFU (S022_R04)
    Video Upper G.I. Scopes Operation IFU (S013_R01)
    Video Upper G.I. Scopes Reprocessing IFU (S019_R04)
    Video Colonoscopes and Accessories – Optional Manual Cleaning Procedures (MK-626 Rev D)
    Video Upper G.I.  Endoscopes and Accessories – Optional Manual Cleaning Procedures (MK-625 Rev D)

  • U.S. URGENT FIELD CORRECTION 17-001.1 Importance of following Validated reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes

    January 16, 2017

    Dear Healthcare Professional,

    PENTAX Medical (“PENTAX”) is writing to inform customers about a potential issue associated with the distal cap of the ED-3490TK and offer recommendations intended to reduce the potential risk for contamination and subsequent patient infection. We also want to remind customers to follow the validated manual reprocessing instructions that PENTAX issued to all PENTAX Model ED-3490TK duodenoscope customers in February 2016. During manufacturing of ED-3490TK duodenoscopes, silicone adhesive is applied to the distal tip prior to affixing the distal cap. In some instances, cracks or gaps may form in the adhesive that may be vulnerable to fluid ingress and soiling. 
    PENTAX is working closely with the FDA to further evaluate and mitigate the potential risk of infection associated with leakage, if leakage were to occur, into or out of the distal cap area.  

    Action Steps:

    The validated manual reprocessing procedures included in the current Instructions for Use (S041 R01) remain the same. PENTAX reminds its customers of the importance of using the ED-3490TK according to its current labeling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the current Instructions for Use for manual reprocessing of these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required. 

    Additionally, PENTAX recommends that you immediately remove from use any ED-3490TK duodenoscope that shows visible signs of wear or physical damage. Continuing to use devices with integrity issues (i.e. holes, cracks, kinks and scratches) can contribute to persistent device contamination and subsequent patient infection.   

    PENTAX will provide annual inspection and servicing to all customers with ED-3490TK duodenoscopes. During on-site inspections, PENTAX field staff will assess duodenoscope functionality and will send duodenoscopes for in-house servicing to recondition worn parts, as needed. PENTAX will contact your facility to schedule time to inspect your ED-3490TK duodenoscope inventory and heightened vigilance will be applied to the integrity of the distal cap during these inspections.

    PENTAX regrets any inconvenience and encourages any facility or institution with questions or requests for further information or assistance regarding this Communication to contact PENTAX Medical Customer Support at 1-800-431-5880.

    Adverse events or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program and to PENTAX as soon as possible at
    vigilance@pentaxmedical.com.

    If you have any questions regarding this action, please feel free to contact us at:
    Tel: 1-800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST) 
    Fax: 201-799-4063 (alternate 201-391-4189) 
    Email: customeradvisories@pentaxmedical.com 

    PENTAX will issue additional communications as further information becomes available. Please be assured that maintaining patient safety and quality is our utmost priority. 

    Sincerely,

    PENTAX of America, Inc.

  • U.S. URGENT FIELD CORRECTION 17-002 Notification Regarding Requirement to Use Isolation Transformer for PENTAX Medical Models 7245C, 7245C/E, 7245D, 9200C, 9200D, 9310HD, and 9400

    Dear Valued Customer,

    The purpose of this communication is to inform you that PENTAX Medical has become aware that some customers may not have been provided with an isolation transformer when they purchased a PENTAX Medical computer system mounted to a cart. The electrical safety requirements for these systems requires the use of an isolation transformer to protect patients from electrical shock.  


    Identification of Affected Models

    Table 1 provides a list of the affected products.

    Table 1

    Model Number   Product Name
    7245C Computer Digital Video System
    7245C/E Computer Digital Video System 230v  
    7245D Computer Digital Video System
    9200C Digital Video Capture
    9200D Digital Video Capture Module
    9310HD HD - Digital Video Capture
    9400 Laryngeal Strobe


    Customer Instructions

    Enclosed with this letter is a field correction response form. The form identifies the affected computer systems (model and serial numbers) which have been sold to your facility.  Please forward this letter and the enclosures to the department in which the above referenced items are in use.  It is suggested that end user of the affected products complete this form and return it to PENTAX Medical.

    Check if the affected models in Table 1 are in use at your facility are currently connected to an isolation transformer.  The picture below shows the location of the isolation transformer on a sample PENTAX Medical cart.  If the affected product is in use and is NOT connected to an isolation transformer, an isolation transformer can be obtained from PENTAX Medical.  Please request model number ISO-PROMO when contacting PENTAX Medical. 


    Picture on an Isolation Transformer Mounted onto a Cart


    Isolation transformer located under rear of cart


    Contact Information

    If you have any questions regarding this action, please feel free to contact us at:

    Tel:         800-431-5880, select option 1 (ENT), then option 3 (equipment)
    Fax:        201-799-4063 (alternate 201-391-4189)
    Email:    customeradvisories@pentaxmedical.com

    This field correction is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,

    PENTAX of America Inc.

    Department of Quality Assurance & Regulatory Affairs

    Isolation Transformer FSCA Response Form (Editable) MK-897 

    Isolation Transformer FSCA Letter MK-896 Rev. B