Pentax of America Inc recalls Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation e…

Recall date

August 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0318-2017

FDA classification

Class II

Brand / firm

Pentax of America Inc

Sold / distributed

US Nationwide and Japan

Why it was recalled

PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.