Z-2012-2019 Class II Terminated
FDA device recall Z-2012-2019 was initiated by Siemens Medical Solutions USA, Inc on June 12, 2019 and is designated Class II. 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… The recall status is terminated (terminated September 18, 2020). Affected quantity: 5.
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
- 5
Product Description
AXIOM Artis FC, Model Number 5904433
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: 10436 10444 10425 10433 10435