Z-0691-2024 Class II Ongoing
FDA device recall Z-0691-2024 was initiated by Shirakawa Olympus Co., Ltd. on December 4, 2023 and is designated Class II. Reason for recall: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. The recall status is ongoing. Affected quantity: 2210 US; 6002 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- December 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2210 US; 6002 OUS
Product Description
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Reason for Recall
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 04953170287091 04953170339431 04953170411199 All serial numbers