AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is… — Class II medical device recall Z-2081-2014
Terminated recall by AGFA Corp., reported 2014-07-30, distributed nationwide. When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user
| Recall number | Z-2081-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Corp., Greenville, SC, United States |
| Recall initiated | 2014-06-06 |
| Classified | 2014-07-21 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2016-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 216 units |
| Serial numbers | A5410000016, A5410000021, A5410000022, A5410000023, A5410000027, A5410000038, A5410000039, A5410000041, A5410000042, A5410000043, A5410000044, A5410000046, A5410000053, A5410000054, A5410000066, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5410000079, A5410000082, A5410000100, A5410000114 and 189 more |
| Model numbers | 100 |
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 for recall
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2081-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.