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U.S. Department of Health and Human Services

Class 2 Device Recall Mevatron M2 PRIMUS midenergy

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 Class 2 Recall
Mevatron M2 PRIMUS midenergy
see related information
Date Posted February 14, 2008
Recall Status1 Open
Recall Number Z-0686-2008
Recall Event ID 46157
Premarket Notification
510(K) Numbers
K862339  K882729 
Product Classification Accelerator, Linear, Medical - 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, California 94520-1200
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL LABORATORIES, INC.
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