FDA-Device2023-07-26Class I

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

Olympus Corporation of the Americas
Hazard

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

Sold states
US Nationwide Distribution.
Affected count
9,684 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2017-2023

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