Recall Z-0168-2016 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
| Date | Oct 27, 2015 (initiated May 5, 2015) |
| Status | Terminated |
| Reason | potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option. |
| Root cause | Software design |
| Action | Siemens sent Safety Advisory Notices, dated May 5th and 22nd, 2015 to all affected customers to inform them about an update of the Control Console software to correct defects affecting the Control Console with their digital Linear Accelerator. Customers were instructed to ensure everne at their organization is aware of the information in the Advisory Notice. If product was further distributed, please forward Safety Notice to all those affected. For questions regarding this recall call 610-219-6300. |
| Quantity | 158 |
| Distribution | Nationwide Distribution |
| 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 |
| K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc., Mar 15, 2006 |
| 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 |
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |