Syngo Imaging VB36D_HF02 — Class II medical device recall Z-0319-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-12-02, distributed in NC, NE, OH. To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. T
| Recall number | Z-0319-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2015-10-28 |
| Classified | 2015-11-20 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-10-06 |
| Distributed | NC, NE, OH |
| Quantity | 3 |
| Reason classes | software |
| Model numbers | 10014063, 10014064 |
Product
Syngo Imaging VB36D_HF02. Radiological image processing system.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.