Z-1745-2015 Class II Terminated
FDA device recall Z-1745-2015 was initiated by AGFA Healthcare Corp. on May 29, 2015 and is designated Class II. Reason for recall: When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. The recall status is terminated (terminated January 18, 2017). Affected quantity: 233 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2015
- Initiation Date
- May 29, 2015
- Termination Date
- January 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 233 units
Product Description
AGFA DX-D 100 is a mobile digital radiography x-ray system
Reason for Recall
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
Distribution Pattern
US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.
Code Information
A5410000053, A5410000054, A5411000439, A5411000446, A5411000447, A5411000448, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5411000420, A5410000100, A5410000107, A5410000114, A5410000115, A5410000116, A5410000117, A5410000132, A5410000133, A5410000134, A5410000039, A5411000140, A5411000142, A5411000314, A5411000342, A5411000347, A5411000349, A5410000007, A5411000017, A5411000315, A5411000331, A5411000332, A5411000463, A5411000141, A5411000144, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000019, A5411000400, A5411000401, A5411000047, A5411000048, A5411000053, A5410000041, A5411000042, A5411000046, A5411000041, A5411000079, A5411000024, A5411000038, A5411000083, A5411000032, A5411000132, A5411000247, A5411000088, A5411000050, A5411000070, A5411000078, A5411000082, A5411000476, A5411000478, A5411000480, A5411000482, A5411000489, A5411000490, A5411000154, A5411000156, A5411000404, A5411000236, A5411000155, A5411000151, A5411000191, A5411000192, A5411000194, A5411000196, A5411000249, A5411000052, A5411000185, A5411000237, A5411000030, A5411000397, A5411000348, A5411000193, A5411000268, A5411000403, A5411000153, A5411000233, A5411000235, A5411000318, A5411000398, A5411000371, A5410000043, A5411000181, A5411000158, A5411000152, A5411000309, A5411000263, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000468, A5411000469, A5411000470, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000338, A5411000159, A5410000038, A5411000148, A5411000149, A5411000134, A5411000125, A5411000147, A5411000039, A5411000121, A5411000405, A5411000372, A5411000120, A5411000117, A5411000333, A5411000334, A5411000040, A5411000377, A5411000240, A5411000085, A5411000419, A5411000097, A5411000281, A5411000278, A5411000279, A5411000492, A5411000280, A5411000282, A5411000245, A5411000277, A5411000184, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000399, A5411000491, A5411000493, A5411000122, A5411000495, A5411000312, A5410000044, A5411000037, A5411000108, A5411000110, A5411000114, A5411000241, A5411000246, A5411000074, A5411000080, A5411000033, A5411000139, A5411000182, A5411000190, A5411000021, A5411000374, A5411000218, A5411000084, A5411000098, A5411000238, A5411000116, A5411000408, A5411000409, A5410000042, A5411000023, A5411000337, A5411000338, A5411000340, A5411000341, A5411000475, A5411000373, A5410000079, A5410000131, A5410000066, A5410000082, A5411000025, 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