Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
This recall is currently active, issued January 9, 2024. It was issued by Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan.
- Company
- Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan
- Recall Initiated
- December 4, 2023
- Posted
- January 9, 2024
- Recall Number
- Z-0688-2024
- Quantity
- 1929 US; 2200 OUS
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI: 04953170059018 All serial numbers
Root 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