Recall Z-2264-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
syngo Imaging XS. Radiological image processing system.
| Date | Aug 24, 2012 (initiated Jul 18, 2012) |
| Status | Terminated |
| 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". |
| Root cause | Software design |
| Action | Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated July 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. For questions concerning this notice contact your local Siemens Service Rep.. |
| Quantity | 52 |
| Distribution | Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082430 | SYNGO IMAGING XS Siemens AG Medical Solutions, Nov 14, 2008 |