FDA Device recall Z-2264-2012
syngo Imaging XS. Radiological image processing system
- FDA Device
- Class II
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class II recall of syngo Imaging XS. Radiological image processing system by Siemens Medical Solutions Usa, citing there is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2264-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-18 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
syngo Imaging XS. Radiological image processing system.
Reason
There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".
Identifiers
| code_info | Model number 10496279 |
|---|
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-2264-2012%22
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