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Recall Observatory FDA recall evidence

Device product

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

Z-2497-2021

August 17, 2021

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 88560
Status
Terminated
Classification
Class II
Quantity
27 globally (21 US)
Official record key
device-enforcement:Z-2497-2021

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.