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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA III Bronchovideoscope

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  Class 2 Device Recall EVIS EXERA III Bronchovideoscope see related information
Date Initiated by Firm December 04, 2023
Date Posted January 09, 2024
Recall Status1 Open3, Classified
Recall Number Z-0686-2024
Recall Event ID 93583
510(K)Number K201758  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Code Information UDI-DI: 04953170342110 All serial numbers
Recalling Firm/
Manufacturer		 Shirakawa Olympus Co., Ltd.
Azaokamiyama 3-1
Oazaodakura; Nishigo-Mura
Nishishirakawa-Gun Japan
For Additional Information Contact Cynthia Ow
81248-27-2239
Manufacturer 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 2		 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 in Commerce 2600 US; 3214 OUS
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = Olympus Medical Systems Corp.
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