Recall Z-0689-2024
Shirakawa Olympus Co., Ltd. · initiated December 4, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Codes / lots: UDI-DI: 04953170310461; 04953170411250 All serial numbers
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.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-0689-2024
- Initiated
- December 4, 2023
- Posted by FDA
- January 9, 2024
- Product code
- FAJ – Cystoscope And Accessories, Flexible/Rigid
- Quantity
- 4780 US; 10448 OUS
- Distribution
- US Nationwide distribution.
- Recalling firm
- Shirakawa Olympus Co., Ltd., Nishigo-Mura Nishishirakawa-Gun
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0684-2024 Class II | Model No. CYF-5, CystonephrofiberscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | 12/04/2023Open, Classified |
| Z-0685-2024 Class II | Model No. CYF-5R, CystonephrofiberscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | 12/04/2023Open, Classified |
| Z-0686-2024 Class II | Model No. BF-P190, EVIS EXERA III BronchovideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | 12/04/2023Open, Classified |
| Z-0687-2024 Class II | Model No. BF-XP190, EVIS EXERA III BronchovideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | 12/04/2023Open, Classified |
| Z-0688-2024 Class II | Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPEOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | 12/04/2023Open, Classified |
| Z-0690-2024 Class II | Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPEOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | 12/04/2023Open, Classified |
| Z-0691-2024 Class II | Model No. CYF-V2, VISERA Cysto-Nephro VideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | 12/04/2023Open, Classified |
| Z-0692-2024 Class II | Model No. CYF-V2R, VISERA Cysto-Nephro VideoscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | 12/04/2023Open, Classified |