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Pentax of America Inc recalls Video Cytoscopes
Recalled June 21, 2017 · FDA recall Z-2325-2017 · Pentax of America
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. · FDA Class II
Units
1,349 - (Total - US) and 352 (Total - OUS)
Sold at
US Nationwide and Internationally
Description
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.
Product
Video Cytoscopes
Manufacturer(s)
Pentax of America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →