FDA-Device2016-11-02Class II
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.
Pentax of America Inc
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.
Sold states
US Nationwide and Japan
Affected count
3,436 (US) and 14,488 (OUS)
Manufactured in
3 Paragon Dr, Montvale, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0318-2017Don't want to check this manually?
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