Device product
AXIOM Artis FA, Model Number 5904441
Z-2013-2019
Product summary
- Event
- Event 83203
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-2013-2019
Official wording
Reason: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Code information: Serial Numbers: 25328 25349 25382 25403
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.