FDA-Device2023-12-20Class II

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

Olympus Corporation of the Americas
Hazard

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

Sold states
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.
Affected count
75
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0557-2024

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