Device product

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

Z-0066-2026

September 11, 2025

Class I

Product summary

Firm: Olympus Corporation of the Americas
Event: Event 97441
Status: Ongoing
Classification: Class I
Quantity: 361 units US; 258 units OUS
Official record key: device-enforcement:Z-0066-2026

Official wording

Reason: 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.

Code information: Model No. BF-XT190; UDI: 4953170402470; All Serial No.

Distribution pattern: US Nationwide Distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.