Reported Dec 6, 2023 · Ongoing
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aizu Olympus Co., Ltd. · 3 Chome 1-1 · Aizuwakamatsu · N/A
Is this the product you have?
- PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Lot codes and dates
UDI-DI 04953170363672 Serial Numbers 294271626044972502056
- Amount recalled
- 24 incorrectly repaired units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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