BEUDAMED
    FDA Recall Terminated

    Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

    Recall: Z-0897-2016 · Initiated January 20, 2016

    Recall

    Recall Number
    Z-0897-2016
    Event Number
    73088
    Firm
    Integrated Medical Systems Inc
    FEI Number
    3010663403
    Product Code
    GCQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 20, 2016
    Terminated
    October 13, 2016
    Address
    3200 2nd Ave N, Birmingham, AL, 35222-1212

    Description

    Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

    Reason

    If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

    Action

    The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.

    Distribution

    Distributed US (nationwide) and in Australia.

    Quantity

    5 instruments