Aizu Olympus Co., Ltd. 2023-12-06 Health serious FDA
Health · FDA · Recall #FDA-Z-0419-2024
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE Recall
Issued December 6, 2023 · Aizu Olympus Co., Ltd.
In December 2023, Aizu Olympus Co., Ltd. recalled the PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Aizu Olympus Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Aizu Olympus Co., Ltd.
- Category
- Health
- Recall date
- December 6, 2023
- Units affected
- Not reported
- Sold at
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- Recall number
- FDA-Z-0419-2024
- Made in
- Japan
- Issuing agency
- FDA
In context
- Aizu Olympus Co., Ltd. has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.