AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic… — Class II medical device recall Z-2056-2019
Terminated recall by Agfa N.V., reported 2019-08-07, distributed nationwide. The exposed area of fluo exams possibly does not match the active area of the detector within specified limits
| Recall number | Z-2056-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Agfa N.V., Mortsel, N/A, Belgium |
| Recall initiated | 2019-06-27 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2020-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| Serial numbers | 00925, 00945, 00949, 1136 |
| Model numbers | 800 |
Product
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.
Reason for recall
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
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-2056-2019. 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.