FDA-Device2025-10-22Class I

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Olympus Corporation of the Americas
Hazard

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Sold states
US Nationwide Distribution.
Affected count
116 units US; 705 units OUS
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0067-2026

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