Recall Z-1077-2013 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
| Date | Apr 10, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| Reason | A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc. |
| Root cause | Software design |
| Action | Siemens sent an Urgent Medical Device Correction letter with update instructions to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your responsible Siemens Service Engineer or Application Specialist. |
| Quantity | 101 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Dec 12, 2012 |