FDA-Device2020-06-17Class II
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Olympus Corporation of the Americas
Hazard
Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
Sold states
US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.
Affected count
19
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2292-2020Don't want to check this manually?
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