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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA BFXT160 Bronchofibervideoscope

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  Class 2 Device Recall EVIS EXERA BFXT160 Bronchofibervideoscope see related information
Date Initiated by Firm August 17, 2021
Create Date September 21, 2021
Recall Status1 Terminated 3 on January 12, 2024
Recall Number Z-2497-2021
Recall Event ID 88560
510(K)Number K023984  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Code Information 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms
484-896-5688
Manufacturer Reason
for Recall		 A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
FDA Determined
Cause 2		 Under Investigation by firm
Action On August 17, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Olympus will repair your unit free of charge. An Olympus representative will contact you to make arrangements for return of your affected bronchoscope. If you have further questions about this recall, please contact laura.storms@olympus.com for additional information.
Quantity in Commerce 27 globally (21 US)
Distribution US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = THE OLYMPUS OPTICAL CO.
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