FDAFDA · Food and drugs·Recall number Z-2081-2014
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.
Published July 30, 2014 · Recall initiated: June 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AGFA Corp.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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