Z-2025-2019 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
- 19
Product Description
AXIOM Artis dFC, Model Number 7727717
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: 40072 40031 40075 40070 40032 40067 40064 40065 40061 40017 40066 40071 40059 40038 40029 40039 40048 40073 40062