Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
FDA Recall Z-0690-2024 · Posted 2024-01-09
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Recalling FirmShirakawa Olympus Co., Ltd.
Recall StatusOpen, Classified
Product CodeFAJ
Date Initiated2023-12-04
Product Quantity1547 US; 2772 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.
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 [email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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