Recall Z-1059-2015 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONC
| Date | Feb 5, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission. |
| Root cause | Component design/selection |
| Action | Siemens sent a Customer Advisory Notice Letter TH016/14/S, dated December 19, 2014, to end users that identified the product, problem, and actions to be taken. End users were advised to read the Field Safety Notice and include it with the User's Manual until the hardware update is completed. |
| Quantity | 310 |
| Distribution | Worldwide Distribution - US Nationwide 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 |
| K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc., Mar 15, 2006 |
| K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc., Dec 27, 2007 |
| K982502 | GENESIS IMRT LINEAR ACCELERATOR Siemens Medical Solutions USA, Inc., Jul 31, 1998 |
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |