FDA Device recall Z-0374-2017
SOMATOM Definition Flash system, x-ray, tomography, computed
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of SOMATOM Definition Flash system, x-ray, tomography, computed by Siemens Medical Solutions Usa, citing hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0374-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-19 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Definition Flash system, x-ray, tomography, computed
Reason
Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
Identifiers
| code_info | Model Numbers: 8098027 10430603 |
|---|
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-0374-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.