FDA Device recall Z-0319-2016
Syngo Imaging VB36D_HF02
- FDA Device
- Class II
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class II recall of Syngo Imaging VB36D_HF02 by Siemens Medical Solutions Usa, citing to provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0319-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-28 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | NC, NE, OH |
Product
Syngo Imaging VB36D_HF02. Radiological image processing system.
Reason
To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.
Identifiers
| code_info | model# 10014063 and 10014064 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0319-2016%22
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