Recall Z-1489-2017 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Mevatron M2/Primus Mid-Energy PRIMUS HI
| Date | Feb 14, 2017 |
| Status | Terminated |
| Reason | Software update |
| Root cause | Software design |
| Action | Siemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option. |
| Quantity | 80 systems |
| Distribution | Distributed throughout the United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |