FDA Device recall Z-0265-2020
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system by Siemens Medical Solutions Usa, citing SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0265-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-24 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | GA, IN, MO, MS, NJ, OH, PA |
Product
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Reason
SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
Identifiers
| code_info | software syngo CT VA20A_SP2 and active Guide&GO license |
|---|
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-0265-2020%22
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