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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax

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 Class 2 Device Recall Pentaxsee related information
Date Initiated by FirmJanuary 29, 2025
Date PostedFebruary 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1237-2025
Recall Event ID 96164
510(K)NumberK231249 
Product Classification Endoscope, accessories, image post-processing for color enhancement - Product Code PEA
ProductPENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
Code Information UDI: 04961333252145 Serial Numbers: A0038A0431 A0038A0433 A0038A0435 A0038A0447 A0038A0451 A0038A0452 A0038A0454 A0038A0458 A0038A0460 A0038A0474 A0038A0475 A0038A0479 A0038A0486 A0038A0488 A0038A0489 A0038A0492 A0038A0494 A0038A0496 A0038A0497 A0038A0500 A0038A0502 A0038A0503 A0038A0507 A0038A0513 A0038A0514 A0038A0516 A0038A0527 A0038A0529 A0038A0536 A0038A0538 A0038A0539 A0038A0541 A0038A0557 A0038A0558 A0038A0560 A0038A0563 A0038A0566 A0038A0568 A0038A0570 A0038A0573 A0038A0574 A0038A0575 A0038A0577 A0038A0579 A0038A0583 A0038A0584 A0038A0585 A0038A0594 A0038A0595 A0038A0596 A0038A0597 A0038A0598 A0038A0599 A0038A0600 A0038A0601 A0038A0602 A0038A0605 A0038A0606 A0038A0607 A0038A0608 A0038A0609 A0038A0610 A0038A0613 A0038A0615 A0038A0616 A0038A0617 A0038A0618 A0038A0619 A0038A0621 A0038A0622 A0038A0623 A0038A0624 A0038A0625 A0038A0630 A0038A0636 A0038A0638 A0038A0639 A0038A0640 A0038A0644 A0038A0645 A0038A0646 A0038A0647 A0038A0648 A0038A0654 A0038A0762 A0038A0786 A0038A0794 A0038AA005 A0038AA010 A0038AA022 A0038AA030 A0038AA039 A0038AA057 A0038AA066 A0038AA067 A0038AA069 A0038AB005 A0038AB008 A0038AB012 A0038AB022 A0038AB023 A0038AB024 A0038AB049 A0038AB055 A0038AB056 A0038AB060 A0038AB063 A0038AB084 A0038AB088 A0038AB124 A0038AB125 A0038AB129 A0038AB130 A0038AB131 A0038AB144 A0038AB152 A0038AB162 A0038AB163 A0038AB164 A0038AB168 A0038AB169 A0038AB170 A0038AB171 A0038AB172 A0038AB180 A0038AB181 A0038AB183 A0038AB184 A0038AB186 A0038AB188 A0038AB189 A0038AB193 A0038AB194 A0038AB195 A0038AB197 A0038AB198 A0038AB200 A0038AB205
Recalling Firm/
Manufacturer		 Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information ContactSAME
973-628-2199
Manufacturer Reason
for Recall		During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
FDA Determined
Cause 2		Device Design
ActionPentax issued URGENT i20c Endoscope User Notification-Precautions when using PENTAX Medical i20c endoscopes with EPK-i8020c Processor Letter on 1/29/25 certified USPS Mail. The letter states reason for recall, health risk and action to take: Customer Instructions: Perform a pre-use inspection according to the Instructions for Use to make sure that there are no foreign objects, scratches, chips, or other abnormalities on the light guide. Do not use OE (Optical Enhancement) mode in cases where there is bleeding such as hematemesis or hematochezia, or where a lot of bleeding was observed during an endoscopic examination or procedure. Use normal observation mode and set the illumination brightness to the minimum necessary. If you notice any abnormalities, such as the observed image being reddish or darker than normal, discontinue use and immediately remove the endoscope from the patient while keeping the endoscope at a distance from the mucous membrane. The temperature at the tip of the endoscope could rise and may cause thermal injury to the patient's mucous membranes. After removing the endoscope, turn off the video processor lamp. Check the distal end of the endoscope, remove any attached patient material, and confirm that the light guide is normal before using it again. If you cannot completely remove all patient material from the distal end of the endoscope, discontinue use and contact PENTAX Medical service facility and request repairs. Please download the Instructions for use (IFU) from the PENTAX Medical online IFU library at https://ifu.pentaxmedical.com for the following products: Models EPK-i8020c; EC38-i20cL; EG29-i20c. Further Actions by PENTAX Medical: PENTAX Medical is currently considering countermeasures that will help to further reduce the potential risks mentioned above. PENTAX Medical will duly notify you when we are ready to implement the changes. Contact Information: Please indicate through the attached response form that you have received and
Quantity in Commerce138 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PEA
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