Skip to content
Recall Observatory FDA recall evidence

Device product

Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE

Z-0689-2024

December 04, 2023

Class II

Product summary

Firm
Shirakawa Olympus Co., Ltd.
Event
Event 93583
Status
Ongoing
Classification
Class II
Quantity
4780 US; 10448 OUS
Official record key
device-enforcement:Z-0689-2024

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: 04953170310461; 04953170411250 All serial numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.