FDA Device recall 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 physi…
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of 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 physi… by Agfa, citing when liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2081-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-06 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa |
| Distribution | US |
Product
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.
Reason
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
Identifiers
| code_info | Serial # A5410000053, A5410000054, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A54110…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, A5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2081-2014%22
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