BEUDAMED
    FDA Recall 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.

    Recall: Z-0636-2017 · Initiated August 15, 2016

    Recall

    Recall Number
    Z-0636-2017
    Event Number
    75306
    Firm
    Pentax of America Inc
    FEI Number
    1000080301
    Product Code
    FDF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 15, 2016
    Posted
    November 19, 2016
    Terminated
    March 8, 2018
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    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.

    Reason

    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).

    Action

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

    Distribution

    US Nationwide and Japan

    Quantity

    5,090 (US) and 14,209 (OUS)