Z-2014-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- June 12, 2019
- Termination Date
- September 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
AXIOM Artis MP, Model Number 5904466
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Serial Numbers: 20334 20052 20303 20238 20242 20322 20282 20363 20338 20295 20348 20172 20264 20367 20258 20265 20250 20249 20281 20243 20339 20321 20294 20254