Z-2027-2019 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
- 53
Product Description
AXIOM Artis dBC, Model Number 7728392
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: 44125 44151 44101 44246 44185 44262 44263 44199 44105 44084 44080 44072 44243 44198 44171 44275 44215 44255 44081 44242 44265 44189 44289 44145 44060 44144 44184 44286 44223 44068 44193 44244 44201 44251 44229 44304 44152 44136 44254 44277 44279 44268 44206 44278 44259 44260 44168 44267 44110 44218 44165 44271 44135