FDA-Device2017-06-21Class II
Video Naso pharyngo Laryngoscopes
Pentax of America Inc
Hazard
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
Sold states
US Nationwide and Internationally
Affected count
1,349 - (Total - US) and 352 (Total - OUS)
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
Video Naso pharyngo Laryngoscopes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2017Don't want to check this manually?
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