Recall Z-1282-2015 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
| Date | Mar 16, 2015 (initiated Jan 21, 2015) |
| Status | Terminated |
| Reason | There is a potential safety risk when using LANTIS server software with operating systems with which it has not been validated or released which can lead to an incorrect treatment to the patient. |
| Root cause | Use error |
| Action | Siemens sent an Customer Advisory Notice, dated January 21, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed the risk associated with use of more recent operating systems with LANTIS Server Software. Customers were warned against the use of more recent operating systems to ensure the LANTIS system remains in the validated configuration. In the interest of safety, we ask you to perform the above preventive measures and inform all affected personnel immediately. Please include this |
| Quantity | 87 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972275 | LANTIS TREATSTATION Siemens Medical Solutions USA, Inc., Sep 8, 1997 |