Recall Z-2174-2014 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
| Date | Aug 10, 2014 (initiated May 28, 2014) |
| Status | Terminated |
| Reason | A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient. |
| Root cause | Use error |
| Action | An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users. |
| Quantity | 160 |
| Distribution | Nationwide and ROW, including Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031764 | ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES Siemens Medical Solutions USA, Inc., Sep 5, 2003 |
| K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc., Dec 27, 2007 |
| K790688 | MEVATRON 67 Siemens Medical Laboratories, Inc., Apr 23, 1979 |
| K982502 | GENESIS IMRT LINEAR ACCELERATOR Siemens Medical Solutions USA, Inc., Jul 31, 1998 |