Recall Z-0465-2013 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
| Date | Dec 3, 2012 (initiated Jun 20, 2012) |
| Status | Terminated |
| Reason | Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could |
| Root cause | Software design |
| Action | The firm, Siemens, sent "Update Instruction SY050/12/S" on June 20, 2012 to its consignees/customers. The Update Instructions described the product, problem and actions to be taken. It also provides a software update. If you have any questions call 610-219-4834 or email: anastasia.mason@siemens.com. |
| Quantity | 15 |
| Distribution | Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093612 | SYNGO.PLAZA Siemens AG Medical Solutions, Mar 4, 2010 |