Device product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Z-0923-2026
Product summary
- Event
- Event 98101
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35
- Official record key
device-enforcement:Z-0923-2026
Official wording
Reason: It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Code information: N/A
Distribution pattern: U.S. Nationwide distribution.
Derived failure modes
-
Unknown
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.