Recall Z-0522-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
syngo.plaza Image processing system
| Date | Jan 11, 2012 (initiated Sep 21, 2011) |
| Status | Terminated |
| Reason | Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer. |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA sent a Customer Safety Advisory Notice dated March 10, 2011 to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the customer of the potential issues and provides additional information on the implemented resolution. For further questions please call (610) 219-4834. |
| Quantity | 1 |
| Distribution | Nationwide Distribution New York |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093612 | SYNGO.PLAZA Siemens AG Medical Solutions, Mar 4, 2010 |