FDA Medical Device Recalls (openFDA)
AGFA Healthcare Corp.: AGFA DX-D 100 is a mobile digital radiography x-ray system
- Recall number
- Z-1745-2015
- Recalling firm
- AGFA Healthcare Corp.
- Product
- AGFA DX-D 100 is a mobile digital radiography x-ray system
- Status
- Terminated
- Initiated
- 2015-05-29
- Posted
- 2015-06-10
- Terminated
- 2017-01-18
- Reason
- When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K103597"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28