Agfa DX-D 100 system-Digital Radiography mobile X-ray System — Class II medical device recall Z-1462-2024
Ongoing recall by Agfa N.V., reported 2024-04-10, distributed nationwide. Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube h
| Recall number | Z-1462-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa N.V., Mortsel, Belgium |
| Recall initiated | 2024-02-23 |
| Classified | 2024-04-02 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CN, CO, CZ, DE, ES, FI, FR, GB, GR, IT, KW, LU, MX, MY, NO, NZ, PE, PL, RO, SA, SE, SG |
| Quantity | 541 units |
| UPC / GTIN / UDI-DI | 05414904272725 |
| Serial numbers | A5411000451, A5411001000, A5411001001, A5411001002, A5411001003, A5411001004, A5411001005, A5411001006, A5411001007, A5411001012, A5411001018, A5411001031, A5411001032, A5411001033, A5411001034, A5411001035, A5411001036, A5411001037, A5411001038, A5411001039, A5411001041, A5411001061, A5411001062, A5411001063, A5411001064 and 475 more |
| Model numbers | 0300, 0400, 050, 5411, A5411 |
Product
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400
Reason for recall
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
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-1462-2024. 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.