Summary
The FDA issued a Class II for Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE by Shirakawa Olympus Co., Ltd.. Reason: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatib.
Details
Source
Device Recall
External ID
Z-0689-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Lot/Code Info: UDI-DI: 04953170310461; 04953170411250 All serial numbers
Quantity Affected: 4780 US; 10448 OUS
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
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-04
Company
Nishishirakawa-Gun
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Shirakawa Olympus Co., Ltd. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Shirakawa Olympus Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Shirakawa Olympus Co., Ltd. have FDA actions?
Shirakawa Olympus Co., Ltd. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0689-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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