AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic — Class II medical device recall Z-2202-2020
Terminated recall by Agfa N.V., reported 2020-06-10, distributed nationwide. Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the d
| Recall number | Z-2202-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa N.V., Mortsel, N/A, Belgium |
| Recall initiated | 2020-04-06 |
| Classified | 2020-06-03 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2023-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| Serial numbers | 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, 1404 |
| Model numbers | 800 |
Product
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following 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
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
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-2202-2020. 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.