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Recall Observatory FDA recall evidence

Device product

Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

Z-2011-2023

June 08, 2023

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92362
Status
Ongoing
Classification
Class I
Quantity
1535 units
Official record key
device-enforcement:Z-2011-2023

Official wording

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

Code information: All serial numbers BF-XT40** OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 UDI: 04953170055980 BF-P60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 UDI: 04953170339288 BF-MP60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 UDI: 04953170338394 BF-1T60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 UDI: 04953170339264

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.