Recall Z-1704-2015 ยท LMD System, Digital Image Communications, Radiological
Siemens Medical Solutions USA, Inc
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints.
| Date | Jun 2, 2015 (initiated May 6, 2015) |
| Status | Terminated |
| Reason | A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay. |
| Root cause | Software design |
| Action | Siemens sent an Safety Advisory Notice, dated May 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were given work around instructions to follow and informed that a software fix would be implemented to permanently resolve the issue. For further questions please call (610) 219-6300. |
| Quantity | 131 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.