Recall Z-0980-2015 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2, MEVATRON KD, MEVATRON KDS, MEVATRON 77, MEVATRON K7467, MEVATRON 7767, MEVATRON K80
| Date | Jan 15, 2015 (initiated Dec 2, 2014) |
| Status | Terminated |
| Reason | Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose calculation, or an overdose and serious injury may occur. |
| Root cause | Component design/selection |
| Action | An urgent field safety notice, dated December 2, 2014, was sent to end users advising them to use only Siemens' authorized components for patient treatments as described in the operator's manual. |
| Quantity | 320 |
| Distribution | Worldwide Distribution - US Nationwide including Canada and Mexico. |
| FDA record | Open on fda.gov |