—#188993

Product

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K023984
Affected lot / code info: 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

Timeline

Recall initiated: 2021-08-17
Terminated: 2024-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.