PlainRecalls
FDA Devices Critical Class I Ongoing

Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Reported: July 26, 2023 Initiated: June 8, 2023 #Z-2017-2023

Product Description

Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Reason for Recall

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Details

Units Affected
9,684 units
Distribution
US Nationwide Distribution.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190. Recalled by Olympus Corporation of the Americas. Units affected: 9,684 units.
Why was this product recalled?
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 26, 2023. Severity: Critical. Recall number: Z-2017-2023.