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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 IIIsee related information
Date Initiated by FirmJuly 20, 2022
Create DateAugust 19, 2022
Recall Status1 Completed
Recall NumberZ-1559-2022
Recall Event ID 90664
510(K)NumberK201758 
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
ProductEVIS 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 ContactCynthia 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
ActionAn 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.
DistributionUS Nationwide distribution in the states of FL, IL, NC, PA & TX.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = EOQ
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