Z-2292-2020 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
June 17, 2020
Initiation Date
May 5, 2020
Termination Date
September 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19

Product Description

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

Reason for Recall

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

Distribution Pattern

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

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