Device 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.
Z-2056-2019
Product summary
- Firm
- Agfa N.V.
- Event
- Event 83400
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-2056-2019
Official wording
Reason: The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Code information: Model/Serial Number/s: 00925, 00945, and 00949, 1136
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.