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Pentax of America Inc recalls Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation eq
Recalled November 2, 2016 · FDA recall Z-0318-2017 · Pentax of America
Hazard
PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs. · FDA Class II
Units
3,436 (US) and 14,488 (OUS)
Sold at
US Nationwide and Japan
Description
PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
Product
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
Manufacturer(s)
Pentax of America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →