Recall Z-1013-2015 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
| Date | Jan 26, 2015 (initiated Jan 2, 2015) |
| Status | Terminated |
| Reason | Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem. |
| Root cause | Software Design Change |
| Action | A customer advisory notice, dated January 2, 2015, was sent to end users which identified the product, problem, and action to be taken. It was recommended that customers use only manual registration with the 6 degrees of freedom option disabled, which provides the correct offset values. A software update will be deployed once a solution is available. |
| Quantity | 3 |
| Distribution | UT, WI, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142434 | ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 Siemens Medical Solutions USA, Inc., Nov 21, 2014 |