Home / Recalls / Olympus Corporation of the Americas / Z-2497-2021

Z-2497-2021 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
September 29, 2021
Initiation Date
August 17, 2021
Termination Date
January 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27 globally (21 US)

Product Description

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

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.

Distribution Pattern

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

Code Information

1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060

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