Device 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
Z-2202-2020
Product summary
- Firm
- Agfa N.V.
- Event
- Event 85599
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-2202-2020
Official wording
Reason: Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
Code information: Serial Numbers: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, and 1404
Distribution pattern: US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.
Derived failure modes
-
Unknown
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible