BEUDAMED
    FDA Enforcement Class II Terminated

    Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

    Recall: Z-0889-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0889-2016
    Event ID
    73088
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integrated Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    January 20, 2016
    Classification Date
    February 25, 2016
    Termination Date
    October 13, 2016
    Address
    3200 2nd Ave N, N/A, Birmingham, AL, 35222-1212, United States

    Description

    Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric 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.

    Code Info

    Serial Numbers: 2005030,2800270,2007268,2802306,2802294,2108696,2801707,2006928,2201349,2904573, 2108936,2006513,2107568,2801235,2800468,2200301,2006896,2802237,2802245,2109496, 2109225,2006520,2200358,2200372,2200370,2200350,2200356,2200364,2200351,2200345, 2005915,2109239,2109237,2904265,2108385,2100007,2904378,2801427,2200930,2107811, 2700057,2004864,2004924,2800273,2109999,2100088,2301603,2107560,2200701,2200648, 2904362,2802353,2802234,2801828,2801792,2903393,2903491,2109241,2109087,2109090, 2201179,2109261,2109234,2802808,2801887,2801892,2007452,2801960,2006598,2903718, 2007242,2007253,2903751,2006554,2006560,2802465,2007275,2004893,2802541,2903876, 2903913,2200971,2700124,2904046,2904425,2007142,2802500,2904240,2109319,2800517, 2802466,2802455,2200168,2006418,2200172,2006479,2108689,2201411,2201402,2005274, 2005123,2005141,2201410,2201389,2903348,2800505,2006883,2801725,2200481,2903648, 2903632,2108188,2108969,2109228,2109233,2802031,2802017,2802028,2802016,2802029, 2108350,2108320,2801583,2903806,2904150,2007033,2903029,2802758,2802794,2802793, 2005497,2005545,2700076,2903964,2903965,2903969,2201427,2100108,2007401,2802654, 2005642,2802394,2903060,2903059,2903756,2200703,2200988,2201112,2903499,2904701, 2802756,2005665,2800338,2108452,2100110,2201023,2301893,2301911,2904358,2904345, 2904344,2904356,2904336,2802111,2005706,2005255,2200750,2200766,2200880,2200769, 2200774,2005599,2802920,2006131,2006639,2006641,2006642,2006638,2006640,2006632, 2006628,2006635,2006634,2903927,2005006,2904212,2903346,2802333,2904016,2903343

    Distribution

    Distributed US (nationwide) and in Australia.

    Quantity

    190 instruments