Device product
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Z-0686-2024
Product summary
- Event
- Event 93583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2600 US; 3214 OUS
- Official record key
device-enforcement:Z-0686-2024
Official wording
Reason: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Code information: UDI-DI: 04953170342110 All serial numbers
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.