FDA recall Z-2292-2020

Olympus Corporation of the Americas · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2020-05-05
Report date
2020-06-17
Termination date
2020-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2292-2020