Z-0684-2024 Class II Ongoing

Recalled by Shirakawa Olympus Co., Ltd. — Nishishirakawa-Gun

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
3457 US; 8122 Global

Product Description

Model No. CYF-5, Cystonephrofiberscope

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: 04953170292323 04953170339417 04953170411144 All serial numbers