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Recall Observatory FDA recall evidence

Device product

Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.

Z-2490-2023

July 27, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92779
Status
Ongoing
Classification
Class II
Quantity
1715 units
Official record key
device-enforcement:Z-2490-2023

Official wording

Reason: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Code information: UDI-DI: 04953170308185, 04953170288968, 04953170308161, 04953170339264, 04953170308277, 04953170339394, 04953170308178, 04953170288876, 04953170308123, 04953170339196, 04953170062988, 04953170339974, 04953170063008, 04953170339998, & 04953170340147; All Serial Numbers.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.