FDA-Device2023-07-26Class I

Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

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
1535 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2011-2023

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