BEUDAMED
    FDA Enforcement Class II Terminated

    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

    Recall: Z-1698-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1698-2017
    Event ID
    76806
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2017
    Initiation Date
    January 20, 2016
    Classification Date
    March 29, 2017
    Termination Date
    April 10, 2017
    Address
    10 S Academy St, Greenville, SC, 29601-2632, United States

    Description

    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

    Reason

    The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.

    Code Info

    A5410000053, A5410000054, A5411000439, A5411000446, A5411000447, A5411000448, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5410000100, A5410000107, A5410000134, A5411000184, A5410000039, A5411000140, A5411000142, A5411000314, A5411000342, A5411000347, A5411000349, A5410000007, A5411000017, A5411000315, A5411000331, A5411000332, A5411000463, A5411000141, A5411000144, A5411000539, A5411000541, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000019, A5411000400, A5411000401, A5411000540, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5411000041, A5411000079, A5411000024, A5411000032, A5411000083, A5411000038, A5411000132, A5411000571, A5411000573, A5411000050, A5411000088, A5411000247, A5411000070, A5411000078, A5411000082, A5411000476, A5411000478, A5411000480, A5411000482, A5411000489, A5411000490, A5411000563, A5411000582, A5411000154, A5411000156, A5411000404, A5411000500, A5411000501, A5411000589, A5411000591, A5411000583, A5411000236, A5411000155, A5411000151, A5411000191, A5411000192, A5411000194, A5411000193, A5411000249, A5411000052, A5411000185, A5411000237, A5411000030, A5411000397, A5411000587, A5411000499, A5411000503, A5411000504, A5411000574, A5411000584, A5411000348, A5411000193, A5411000268, A5411000498, A5411000502, A5411000509, A5411000403, A5411000153, A5411000233, A5411000235, A5411000318, A5411000398, A5411000538, A5411000371, A5410000043, A5411000181, A5411000158, A5411000513, A5411000514, A5411000152, A5411000548, A5411000553, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000468, A5411000469, A5411000470, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000533, A5411000537, A5411000536, A5411000159, A5410000038, A5411000148, A5411000149, A5411000134, A5411000405, A5411000120, A5411000125, A5411000372, A5411000147, A5411000588, A5411000039, A5411000117, A5411000121, A5411000333, A5411000334, A5411000377, A5411000040, A5411000240, A5411000593, A5411000594, A5411000085, A5411000419, A5411000097, A5411000281, A5411000278, A5411000279, A5411000280, A5411000492, A5411000282, A5411000245, A5411000277, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000399, A5411000491, A5411000493. A5411000524, A5411000497, A5411000534, A5411000526, A5411000535, A5411000122, A5411000575, A5411000576, A5411000577, A5411000495, A5411000578, A5410000044, A5411000037, A5411000241, A5411000246, A5411000108, A5411000110, A5411000114, A5411000312, A5411000074, A5411000080, A5411000522, A5411000033, A5411000139, A5411000543, A5411000182, A5411000190, A5411000021, A5411000374, A5411000218, A5411000572, A5411000084, A5411000098, A5411000238, A5411000116, A5411000408, A5411000409, A5410000042, A5410000023, A5411000544, A5411000580, A5411000581, A5411000545, A5411000546, A5411000547, A5411000579, A5411000337, A5411000338, A5411000340, A5411000341, A5411000475, A5411000549, A5411000373, A5411000420, A5410000133, A5410000117, A5410000115, A5410000079, A5410000131, A5410000066, A5410000132, A5410000114, A5410000082, A5410000116, A5411000025, A5411000523, A5411000525, A5411000590, A5411000592, A5411000263, A5411000309, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000363, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000034, A5411000081, A5411000146, A5411000092, A5411000093, A5411000407, A5411000026, A5411000068, A5411000367, A5411000368, A5411000465, A5411000060, A5411000131, A5411000018, A5411000100, A5411000515, A5411000313, A5411000284, A5411000076, A5411000135, A5411000180, A5411000343, A5411000285, A5411000311, A5411000375, A5411000062, A5411000136, A5411000179, A5411000178, A5411000421, A5411000427, A5411000376

    Distribution

    Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada.

    Quantity

    308