Siemens syngo Imaging XS — Class II medical device recall Z-2111-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-07-30, distributed nationwide. Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In
| Recall number | Z-2111-2014 |
|---|---|
| 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 | 2014-06-30 |
| Classified | 2014-07-23 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 141 |
| Reason classes | device malfunction |
| Model numbers | 10496279 |
Product
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced post processing applications.
Reason for recall
Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest , Pixel Lens , Edge enhancement and Histograms . This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel d
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2111-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.