Recall Z-2202-2020 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Agfa N.V.
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
| Date | Apr 6, 2020 |
| Status | Terminated |
| Reason | Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible |
| Root cause | Software design |
| Action | Agfa issued Urgent Field Safety Notice via email on 4/21/20 to consignees, letter states reason for recall, health risk and action to take: Acknowledgment, via a feedback form or email, that the information was received and understood was requested from the consignees. |
| Quantity | 13 units |
| Distribution | US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI. |
| 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 |