Recall Z-0680-2008 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9822693 and 9411588, Siemens Medical Solutions, Concord, CA 94520
| Date | Feb 14, 2008 (initiated Aug 7, 2007) |
| Status | Terminated |
| Reason | Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position. |
| Root cause | Device Design |
| Action | The firm has sent consignees a Customer Safety Advisory Notice on August 7, 2007 informing them that a misplacement of the X and/or Y jaws can occur if interlock #51 Jaw Field Position is asserted and then cleared with the left-hand key rest. The firm recommends that if an interlock issue is encountered tha treatment of the patient be discontined until this issue is resolved. |
| Quantity | 35 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862339 | MEVATRON KD-2 Siemens Medical Laboratories, Inc., Oct 29, 1986 |