Z-1745-2015Class II

AGFA DX-D 100 is a mobile digital radiography x-ray system

Name: Z-1745-2015 AGFA DX-D 100 is a mobile digital radiography x-ray system
Creator: AGFA Healthcare Corp.
Published: 2015-05-29
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2015-05-29 / Terminated

FDA source

AGFA Healthcare Corp. began a recall of AGFA DX-D 100 is a mobile digital radiography x-ray system on 2015-05-29. FDA classified it as Class II and gives the reason as "When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1745-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-06-10
Terminated: 2017-01-18
Recalling firm: AGFA Healthcare Corp.
Product: AGFA DX-D 100 is a mobile digital radiography x-ray system
Product code: IZL System, X-Ray, Mobile
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 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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1745-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1745-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10

Product code IZL

K103597Class IIDx-D 100Agfa Healthcare N.V. / cleared 2011-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)