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Recall Observatory FDA recall evidence

Device product

Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Z-2017-2023

June 08, 2023

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92362
Status
Ongoing
Classification
Class I
Quantity
9,684 units
Official record key
device-enforcement:Z-2017-2023

Official wording

Reason: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Code information: All serial numbers BF-H190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 UDI: 04953170434754 BF-Q190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 UDI: 04953170335198 BF-XT190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190UDI: 04953170402470 BF-1TH190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 UDI: 04953170434778

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.