Recall Z-2056-2019 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Agfa N.V.
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 ima
| Date | Jun 27, 2019 |
| Status | Terminated |
| Reason | The exposed area of fluo exams possibly does not match the active area of the detector within specified limits. |
| Root cause | Device Design |
| Action | The firm sent notification letter dated June 27, 2019 to affected customers. The letter identified the affected product problem and actions to be taken. For questions about this matter,contact your local Agfa Imaging organization 1-877-777-2432 and please reference Problem Record. PRB2000198. |
| Quantity | 4 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180589 | DR 800 with MUSICA Dynamic Agfa Healthcare N.V., Apr 5, 2018 |