FDA Medical Device Recalls (openFDA)
Shirakawa Olympus Co., Ltd.: Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
- Recall number
- Z-0689-2024
- Recalling firm
- Shirakawa Olympus Co., Ltd.
- Product
- Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
- Status
- Open, Classified
- Initiated
- 2023-12-04
- Posted
- 2024-01-09
- Terminated
- not on file
- Reason
- Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Root cause
- Under Investigation by firm
- Action
- On December 4, 2023, the firm notified customers of the recall via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed of the updates to the instructions for use (IFU). Customers were instructed to ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions. Please locate and replace any on-hand copies of the IFU with the updated version. The most current version of the Instructions for Use can be obtained from the Olympus Connect customer web portal at https://www.OlympusConnect.com. New users will need to register. Once registered select the Product Support button on the left navigation bar, select the [Reprocessing Manuals] button, locate the BF-P190 and BF-XP190 Instructions for Use and select the [Download] button. If you require additional information, please contact the firm directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com
- Quantity
- 4780 US; 10448 OUS
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 04953170310461; 04953170411250 All serial numbers
- 510(k) numbers
- ["K221683"]
- PMA numbers
- not on file
- Product code
- FAJ
- Firm FEI
- 3002808148
- Firm city
- Nishigo-Mura Nishishirakawa-Gun
- Firm state
- not on file
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28