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Recall Observatory FDA recall evidence

Device product

Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.

Z-2491-2023

July 27, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92779
Status
Ongoing
Classification
Class II
Quantity
1072 units
Official record key
device-enforcement:Z-2491-2023

Official wording

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

Code information: UDI-DI: 04953170340048, 04953170289064, 04953170340093, 04953170289033, 04953170340116, 04953170308154, & 04953170339240; 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.