Pentax of America Inc recalls Pentax Video Colonoscope 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-0636-2017

FDA classification

Class II

Brand / firm

Pentax of America Inc

Sold / distributed

US Nationwide and Japan

Why it was recalled

Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).

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 Colonoscope 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 lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.