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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-1236-2025
Recall Event ID 96164
510(K)NumberK231249 
Product Classification Endoscope, accessories, image post-processing for color enhancement - Product Code PEA
ProductPENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
Code Information UDI: 04961333252169 Serial Numbers: A002FA0230 A002FA0244 A002FA0246 A002FA0247 A002FA0248 A002FA0259 A002FA0269 A002FA0271 A002FA0272 A002FA0274 A002FA0275 A002FA0278 A002FA0281 A002FA0282 A002FA0283 A002FA0293 A002FA0294 A002FA0299 A002FA0300 A002FA0301 A002FA0303 A002FA0304 A002FA0306 A002FA0307 A002FA0311 A002FA0314 A002FA0315 A002FA0316 A002FA0321 A002FA0324 A002FA0364 A002FA0371 A002FA0372 A002FA0376 A002FA0378 A002FA0381 A002FA0383 A002FA0384 A002FA0388 A002FA0390 A002FA0399 A002FA0408 A002FA0415 A002FA0418 A002FA0419 A002FA0420 A002FA0422 A002FA0423 A002FA0424 A002FA0428 A002FA0432 A002FA0433 A002FA0435 A002FA0436 A002FA0437 A002FA0438 A002FA0439 A002FA0440 A002FA0443 A002FA0445 A002FA0446 A002FA0460 A002FA0462 A002FA0466 A002FA0474 A002FA0476 A002FA0477 A002FA0479 A002FA0485 A002FA0486 A002FA0487 A002FA0491 A002FA0492 A002FA0493 A002FA0496 A002FA0497 A002FA0505 A002FA0506 A002FA0514 A002FA0523 A002FA0539 A002FA0570 A002FA0578 A002FA0579 A002FA0580 A002FA0581 A002FA0592 A002FA0593 A002FA0594 A002FA0595 A002FA0596 A002FA0597 A002FA0604 A002FA0610 A002FA0611 A002FA0612 A002FA0613 A002FA0617 A002FA0619 A002FA0622 A002FA0633 A002FAA002 A002FAA005 A002FAA009 A002FAA010 A002FAA012 A002FAA017 A002FAA018 A002FAA021 A002FAA023 A002FAA024 A002FAA025 A002FAA026 A002FAA029 A002FAA030 A002FAA033 A002FAA034 A002FAA035 A002FAA036 A002FAA038 A002FAA051 A002FAA053 A002FAA056 A002FAA058 A002FAA065 A002FAA067 A002FAB002 A002FAB006 A002FAB018 A002FAB020 A002FAB024 A002FAB025 A002FAB026 A002FAB027 A002FAB029 A002FAB032 A002FAB048 A002FAB049 A002FAB050 A002FAB052 A002FAB053 A002FAB055 A002FAB057 A002FAB074 A002FAB076 A002FAB082 A002FAB084 A002FAB086 A002FAB097 A002FAB130 A002FAB132 A002FAB146
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 Commerce152 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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