Recall Z-0827-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
| Date | Jan 20, 2012 (initiated May 1, 2011) |
| Status | Terminated |
| Reason | The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID. |
| Root cause | Software design |
| Action | The firm initiated their product recall in May 2011 by issuing a "Customer Safety Advisory Notice" informing all customers of the malfunction and providing instructions on how to avoid the error. The issue will be solved with the next version release, planned for June 2011. |
| Quantity | 3 |
| Distribution | Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101666 | SYNGO. PLAZA VA20A Siemens AG Medical Solutions, Aug 10, 2010 |