FDA Device recall Z-2026-2019
AXIOM Artis TC, Model Number 7728350
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of AXIOM Artis TC, Model Number 7728350 by Siemens Medical Solutions Usa, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2026-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-12 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
AXIOM Artis TC, Model Number 7728350
Reason
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.
Identifiers
| code_info | Serial Numbers: 30006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2026-2019%22
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