FDA Device recall Z-2624-2016
SOMATOM Definition AS with software version VA48A-SP2
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of SOMATOM Definition AS with software version VA48A-SP2 by Siemens Medical Solutions Usa, citing due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2624-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-13 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | CA, KY, MI, ND, NE, NY |
Product
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Reason
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
Identifiers
| code_info | Model # 10430603 Serial # 74192 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2624-2016%22
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