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U.S. Department of Health and Human Services

Class 2 Device Recall Bronchovideoscope

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  Class 2 Device Recall Bronchovideoscope see related information
Date Initiated by Firm July 27, 2023
Date Posted August 31, 2023
Recall Status1 Open3, Classified
Recall Number Z-2503-2023
Recall Event ID 92779
510(K)Number K963033  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Olympus Bronchovideoscope, Models BF-3C160.
Code Information UDI-DI: 04953170340031 & 04953170063039; All Serial Numbers.
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
647-999-3203
Manufacturer Reason
for Recall		 Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
FDA Determined
Cause 2		 Labeling Change Control
Action Consignees were mailed an Urgent Medical Device Correction notification dated 7/27/2023 via UPS. The notification asks that consignees inspect their inventory for recalled devices and check clinical areas to see if any remain in use. Consignees are to ensure that all personnel, including clinical staff, are completely knowledgeable of this recall notification and addendum, which instructs users to slide the endotracheal tube along the entire length of the tracheal intubation scope insertion section to confirm compatibility before using on a patient. Consignees are asked to complete and return the provided response form to Sedgwick via email at Olympus7498@sedgwick.com or by fax at 866-552-4917. Any questions about the acknowledgement form may be directed by phone to 866-737-4762. If product has been further distributed, please forward the notification to those secondary consignees and maintain records of your documentation process. Consignees are to report any complaints to Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) and FDA Medwatch. Any further questions are to be directed to Tara Safi by email at Tara.Safi@Olympus.com.
Quantity in Commerce 1004 units
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 AMERICA, INC.
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