FDA Device recall Z-2056-2019
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynam…
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynam… by Agfa N V, citing the exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2056-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-27 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Agfa N V |
| Distribution | US |
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
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Identifiers
| code_info | Model/Serial Number/s: 00925, 00945, and 00949, 1136 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2056-2019%22
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