| | Class 2 Recall
Mevatron M-2 PRIMUS mid-energy |  |
| Date Posted |
February 14, 2008 |
| Recall Number |
Z-0686-2008 |
| 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 |
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.
|
| 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 |
| |
|
|
|
|
