Recall Z-0271-2014 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens syngo.plaza image processing system image processing radiological system
| Date | Nov 13, 2013 (initiated Aug 8, 2011) |
| Status | Terminated |
| Reason | The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems. |
| Root cause | Software design |
| Action | Siemens sent a Customer Safety Advisory Notice dated August 3, 2011, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to forward the Customer Safety Advisory Notice to their customers. If necessary, customers should have the letter translated technically into the local language and copy it themselves. A letter was sent to direct accounts to inform them of the issu and provide instructions to avoid encountering the problem. For questions regarding this recall call 610-219-6300. |
| Quantity | 19 |
| Distribution | Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, 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 |