Z-1698-2017 Class II Terminated
FDA device recall Z-1698-2017 was initiated by AGFA Healthcare Corp. on January 20, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 10, 2017). Affected quantity: 308.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- January 20, 2016
- Termination Date
- April 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 308
Product 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 for Recall
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.
Distribution Pattern
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.
Code Information
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