FDA-Device2025-10-22Class I
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
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
1,070 units US; 2,180 units OUS
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0056-2026More Olympus Corporation of the Americas recalls
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