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OES CYSTONEPHROFIBERSCOPE recallZ-0684-2024 · Shirakawa Olympus Co., Ltd. · initiated Dec 4, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Shirakawa Olympus Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-0684-2024
Status
Open, Classified
Initiated by the company
Dec 4, 2023
Posted by the FDA
Jan 9, 2024
Recalling firm
Shirakawa Olympus Co., Ltd.
Quantity
3457 US; 8122 Global
Product code
FAJ
FDA submissions
K221690
Distribution
US Nationwide distribution.

Product description

Model No. CYF-5, Cystonephrofiberscope

Code information (models, lots, serial numbers)

UDI-DI: 04953170292323 04953170339417 04953170411144 All serial numbers

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K221690 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93583).

Sources and updates

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