BEUDAMED
    FDA Enforcement Class II Terminated

    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

    Recall: Z-2081-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2081-2014
    Event ID
    68567
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    June 6, 2014
    Classification Date
    July 21, 2014
    Termination Date
    June 27, 2016
    Address
    10 S Academy St, Greenville, SC, 29601-2632, United States

    Description

    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

    Reason

    When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.

    Code Info

    Serial # A5410000053, A5410000054, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5411000315, A5411000331, A5411000332, A5411000141, A5411000144, A5411000038, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000333, A5411000334, A5410000038, A5411000019, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5410000016, A5410000039, A5410000021, A5410000023, A5411000074, A5411000080, A5411000024, A5411000184, A5411000193, A5411000196, A5410000100, A5410000114, A5410000115, A5410000116, A5410000117, A5411000342, A5411000343, A5411000344, A5411000366, A5411000368, A5411000237, A5411000027, A5411000020, A5411000021, A5411000132, A5411000070, A5411000078, A5411000082, A5411000154, A5411000156, A54110000107, A5410000082, A5410000066, A5411000236, A5411000155, A5411000151, A5411000148, A5411000149, A5411000134, A5411000120, A5411000125, A5411000147, A5410000079, A5411000185, A5411000191, A5411000192, A5411000194, A5411000239, A5411000052, A5411000030, A5411000314, A5411000348, A5411000268, A5411000347, A5411000349, A5411000140, A5411000142, A5411000097, A5410000022, A5411000017, A5410000027, A5411000153, A5411000233, A5411000234, A5411000235, A5411000318, A5410000044, A5411000037, A5410000043, A5411000181, A5411000158, A5411000152, A5411000263, A5411000309, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000159, A5411000041, A5411000050, A5411000088, A5411000247, A5411000079, A5411000040, A5411000240, A5411000085, A5411000277, A5411000278, A5411000279, A5411000280, A5411000281, A5411000282, A5411000245, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000039, A5411000032, A5411000083, A5411000122, A5411000108, A5411000110, A5411000241, A5411000246, A5411000114, A5411000033, A5411000139, A5411000312, A5411000182, A5411000190, A5411000218, A5411000249, A5411000084, A5411000098, A5411000238, A5411000116, A5410000042, A5411000023, A5411000337, A5411000338, A5411000340, A5411000314, A5411000117, A5411000121, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000363, A5411000034, A5411000025, A5411000081, A5411000146, A5411000092, A5411000093, A5411000026, A5411000068, A5411000131, A5411000060, A5411000018, A5411000100, A5411000313, A5411000284, A5411000076, A5411000135, A5411000180, A5411000285, A5411000311, A5411000286, A5411000062, A5411000136, A5411000178, A5411000179, A5411000283

    Distribution

    USA (nationwide) including the states of AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, WY and Internationally to Canada.

    Quantity

    216 units