Device product
AXIOM Artis dFA, Model Number 7555373
Z-2024-2019
Product summary
- Event
- Event 83203
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39
- Official record key
device-enforcement:Z-2024-2019
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: 50063 50059 50006 50064 50189 50044 50074 50101 51719 50062 50065 50087 50167 50039 50084 51706 51707 50048 50161 50093 50206 50057 50081 50133 50040 50016 50120 50191 51701 50027 51700 50139 50004 50010 50024 50142 50079 50132 50050
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.