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Recall Observatory FDA recall evidence

Device product

TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

Z-0557-2024

September 28, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 93433
Status
Ongoing
Classification
Class II
Quantity
75
Official record key
device-enforcement:Z-0557-2024

Official wording

Reason: Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

Code information: UDI-DI: 04953170340215 & UDI-DI: 04953170061998. Serial numbers: 2515143, 2515181, 2515449, 2515549, 2615760, 2615761, 2615763, 2615825, 2615830, 2615831, 2616057, 2616130, 2616199, 2716417, 2817430, 2917855, 2917867, 2917997, 2918003, 2918010, 2918012, 2918030, 2018337, 2018435, 2018486, 2018543, 2018571, 2018675, 2319768, 2319820, 2510582, 2621001.

Distribution pattern: Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.