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U.S. Department of Health and Human Services

Class 2 Device Recall AGFA Digital Radiography Xray system DXD 100

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  Class 2 Device Recall AGFA Digital Radiography Xray system DXD 100 see related information
Date Initiated by Firm May 29, 2015
Date Posted June 10, 2015
Recall Status1 Terminated 3 on January 18, 2017
Recall Number Z-1745-2015
Recall Event ID 71393
510(K)Number K103597  
Product Classification System, x-ray, mobile - Product Code IZL
Product AGFA DX-D 100 is a mobile digital radiography x-ray system
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  
Recalling Firm/
Manufacturer		 AGFA Healthcare Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 29, 2015, to all affected customers. The letter was either emailed or sent via FedEx to the US customers. When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. Please distribute this information within your facility to all those who need to be aware of the notice. Please complete the feedback form as soon as possible and return it to us. We thank you for your careful attention to this issue and your continued support. If you have any questions about this matter, please contact your local Agfa HealthCare organization: 1-877-777-2432 and please reference PR1411200006 and PR1501190003.
Quantity in Commerce 233 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = AGFA HEALTHCARE N.V.
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