Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS
FDA device recall Z-2111-2014 · posted 2014-07-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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
- Action taken
- Siemens sent a Customer letter dated June 30th, to all affected customers to inform them of a new software version VA70B_0114 that will be introduced to all syngo Imaging XS customers with version VA70A or higher to solve a potential issue regarding miscalculations done for the grey scale values in the functions "Region of Interest", "Pixel Lens", "Edge Enhancement", and "Histograms". For questions regarding this recall call 610-219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 141
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-06-30
- Date posted
- 2014-07-23
- Date terminated
- 2015-02-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |