Z-0689-2024 Class II Ongoing
FDA device recall Z-0689-2024 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: 4780 US; 10448 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
- 4780 US; 10448 OUS
Product Description
Model No. CYF-VH, 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: 04953170310461; 04953170411250 All serial numbers