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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA III

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  Class 2 Device Recall EVIS EXERA III see related information
Date Initiated by Firm July 20, 2022
Create Date August 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-1559-2022
Recall Event ID 90664
510(K)Number K201758  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product EVIS EXERA III Bronchovideoscope
Code Information UDI-DI: 04953170342134; Serial No. 2911858; Model No. BF-XP190.
Recalling Firm/
Manufacturer		 Aizu Olympus Co., Ltd.
1 Chome 1-1
Niiderakita
Aizuwakamatsu Japan
For Additional Information Contact Cynthia Ow
647-999-3203
Manufacturer Reason
for Recall		 The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Field Safety Notice was distributed by the recalling firm on 07/20/2022 notifying consignees that a bronchoscope utilized in a veterinary endoscopy procedure was subsequently distributed as a service loaner in error. The device was utilized in a single procedure on a cat. Actions to be taken by customers include evaluating the situation according to hospital procedure to determine if patient notification or follow up may be required, review patient records and report any potentially adverse events to Olympus and FDA and acknowledge receipt of the recall notification by email or through the Olympus recall portal at https://olympusamerica.com/recall. Customers with any questions may contact Cynthia Ow by phone at (647)999-3203 or by email at Cynthia.Ow@Olympus.com. Customers reporting complaints associated with this recall event are to call Olympus at 1-800-848-9024, option 1.
Distribution US Nationwide distribution in the states of FL, IL, NC, PA & TX.
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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