Z-2023-2019 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
- 32
Product Description
AXIOM Artis dMP, Model Number 7555365
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: 57204 57089 57077 57024 57144 57189 57208 57035 57188 57073 57072 57016 57009 57050 57207 57111 57171 57113 57193 57008 57198 57155 57124 57004 57105 57098 57116 57045 57156 58701 57183 57187