Recall Z-2812-2015 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deli
| Date | Sep 24, 2015 (initiated Aug 5, 2015) |
| Status | Terminated |
| Reason | A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients. |
| Root cause | Software design (manufacturing process) |
| Action | Siemens sent Notification letters to affected customers. The letter identified the affected product, problem and actions to be taken. The letter advise customers that the software fix was rolled out to address multiple safety issues. |
| Quantity | 26 |
| Distribution | Worldwide Distribution and US Nationwide |
| 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 |
| K090683 | SYNGO RT THERAPIST CONNECT Siemens Medical Solutions USA, Inc., May 8, 2009 |
| K103606 | ARTISTE SOLUTION WITH SYS_VB50 UPDATE Siemens Medical Solutions USA, Inc., Apr 15, 2011 |
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |