BEUDAMED
    FDA Enforcement Class II 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 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0636-2017
    Event ID
    75306
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2016
    Initiation Date
    August 15, 2016
    Classification Date
    November 19, 2016
    Termination Date
    March 8, 2018
    Address
    3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States

    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).

    Code Info

    Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK

    Distribution

    US Nationwide and Japan

    Quantity

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