| Class 2 Device Recall Mevatron M2 PRIMUS midenergy |  |
Date Initiated by Firm | August 07, 2007 |
Date Posted | February 14, 2008 |
Recall Status1 |
Terminated 3 on December 01, 2010 |
Recall Number | Z-0686-2008 |
Recall Event ID |
46157 |
510(K)Number | K993425 |
Product Classification |
Linear Medical Accelerator - Product Code IYE
|
Product | Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number :1940035, Siemens Medical Solutions, Concord, CA 94520 |
Code Information |
Serial Numbers: 2507, 2512, 2515, 2516, 2521, 2524, 2526, 2527, 2532, 2573, 2593, 2596, 2611, 2613, 2622, 2644, 2647, 2678, 2689, 2692, 2695, 2699, 2702, 2705, 2722, 2735, 2738, 2745, 2758, 2765, 2767, 2791, 2792, 2794, 2806, 2814, 2816, 2817, 2834, 2845, 2847, 2857, 2875, 2898, 2901, 2906, 2913, 2921, 2929, 2955, 2959, 2961, 2962, 2965, 2968, 2974, 2988, 2995, 3009, 3013, 3016, 3018, 3055, 3057, 3061, 3071, 3078, 3082, 3084, 3089, 2443, 2458, 2469, 2473, 2475, 2476, 2499, 2501, 2503, 2504, 2534, 2545, 2548, 2549, 2551, 2552, 2554, 2556, 2559, 2565, 2566, 2583, 2597, 2618, 2619, 2625, 2642, 2653, 2668, 2673, 2675, 2677, 2684, 2688, 2704, 2706, 2709, 2717, 2719, 2737, 2744, 2746, 2748, 2755, 2789, 2795, 2798, 2799, 2802, 2803, 2804, 2809, 2822, 2831, 2838, 2852, 2861, 2865, 2868, 2876, 2879, 2881, 2884, 2886, 2888, 2895, 2915, 2926, 2932, 2935, 2946, 2947, 2949, 2953, 2969, 2971, 2977, 2981, 2982, 2983, 2984, 2998, 3001, 3006, 3012, 3015, 3048, 3052, 3054, 3056, 3059, 3062, 3065, 3086, 3088, 2449, 2455, 2471, 2495, 2497, 2529, 2576, 2604, 2655, 2707, 2712, 2728, 2736, 2759, 2772, 2778, 2843, 2853, 2873, 2925, 2999, 3035, 3038, 3051, 3063, 3073, 3083, 2465, 2506, 2511, 2517, 2522, 2523, 2543, 2572, 2626, 2628, 2669, 2696, 2698, 2747, 2752, 2818, 2835, 2927, 3045, 2666, and 2909. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 4040 Nelson Ave Concord CA 94520-1200
|
For Additional Information Contact | 925-246-8407 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 in Commerce | 213 units |
Distribution | Worldwide Distribution |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = IYE
|
|
|
|