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Terminated

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.

FDA Recall Z-0636-2017 · Posted 2016-11-19

Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeFDF
Date Initiated2016-08-15
Date Terminated2018-03-08
Product Quantity5,090 (US) and 14,209 (OUS)

Reason for Recall

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).

Firm Action

Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.

Root Cause

Other

Distribution Pattern

US Nationwide and Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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