EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Hazard
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.
What You Should Do
Remedy
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.
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Products
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
- Brand
- Olympus Corporation of the Americas
- UPC
- 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060
Units Affected
27 globally (21 US)