FDA Device recall Z-1518-2016
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body by Siemens Medical Solutions Usa, citing software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1518-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-02 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Reason
Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
Identifiers
| code_info | Model Number: 7740769 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c. |
|---|
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-1518-2016%22
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