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

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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