FDA-Device2023-07-26Class I

Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

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
284 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2014-2023

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