Recall Z-0048-2013 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens syngo.plaza radiological image processing system.
| Date | Oct 11, 2012 (initiated Jun 6, 2012) |
| Status | Terminated |
| Reason | Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing. |
| Root cause | Software design |
| Action | The firm initiated this correction on June 6, 2012 by issuing update instructions SY129/12/S to consignees. A script will be distributed to all potential affected customer systems which will prevent data loss by setting the delete protection on all affected studies. |
| Quantity | 11 |
| Distribution | Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093612 | SYNGO.PLAZA Siemens AG Medical Solutions, Mar 4, 2010 |