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Recall Observatory FDA recall evidence

Device product

ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

Z-2292-2020

May 05, 2020

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 85621
Status
Terminated
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-2292-2020

Official wording

Reason: Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.

Code information: Serial Numbers 2901130 2901567 2901655 2901548 7900416 7900638 7900546 7900590 2901700 2901410 2901456 2901451 2901414 2901435 2901428 2901437 2901624 2901753 2901788 2801008 2801059 2801069 2801072 2801046 2801023 2901343 2801076 2801010 2801009 2801019 2901891 7900545 2801059 TEST1 TEST2 2801072 7900644 2901529 2801051 7900360 7900187 7900362 7900542 7900589 2801008 7900264 2801058 2801007 2801012 7900612

Distribution pattern: US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.