FDA-Device2023-07-26Class I

Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

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
17,609 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2016-2023

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