Device product
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
Z-1502-2020
Product summary
- Firm
- Agfa N.V.
- Event
- Event 85028
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1502-2020
Official wording
Reason: Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Code information: Serial Numbers: 00949, 1161
Distribution pattern: US Nationwide distribution in the states of FL, VA.
Derived failure modes
-
Unknown
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.