Olympus Corporation of the Americas 2023-11-15 Health critical FDA
Health · FDA · Recall #FDA-Z-0194-2024
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 Recall
Issued November 15, 2023 · Olympus Corporation of the Americas
In November 2023, Olympus Corporation of the Americas recalled the EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
What you should do
- 1 Stop using EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Olympus Corporation of the Americas 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
- Olympus Corporation of the Americas
- Category
- Health
- Recall date
- November 15, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution
- Recall number
- FDA-Z-0194-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.