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Class 2 Device Recall Mevatron M2 PRIMUS hienergy |
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Date Initiated by Firm |
August 07, 2007 |
Date Posted |
February 14, 2008 |
Recall Status1 |
Terminated 3 on December 01, 2010 |
Recall Number |
Z-0687-2008 |
Recall Event ID |
46157 |
510(K)Number |
K993425
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Product Classification |
Linear Medical Accelerator - Product Code IYE
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Product |
Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 4504200, Siemens Medical Solutions, Concord, CA 94520 |
Code Information |
Serial Numbers: 2701, 2768, 2823, 2827, 2828, 2836, 2839, 2842, 2846, 2863, 2867, 2887, 2893, 2896, 2899, 2911, 2912, 2914, 2931, 2933, 2934, 2941, 2954, 2958, 2972, 2991, 2996, 2997, 3004, 3014, 3019, 3025, 3027, 3039, 3049, 3068, 3069, 3075, 3077, 3079, 3087, 3092, 2733, 2773, 2782, 2783, 2785, 2793, 2796, 2797, 2805, 2815, 2829, 2832, 2833, 2851, 2854, 2862, 2866, 2869, 2871, 2878, 2883, 2891, 2892, 2897, 2902, 2903, 2904, 2905, 2916, 2917, 2918, 2919, 2922, 2923, 2924, 2938, 2942, 2944, 2948, 2956, 2957, 2963, 2964, 2966, 2967, 2973, 2975, 2976, 2978, 2979, 2986, 2989, 2992, 2993, 2994, 3002, 3005, 3007, 3008, 3011, 3017, 3024, 3028, 3031, 3033, 3034, 3036, 3042, 3043, 3044, 3046, 3064, 3067, 3072, 3074, 3081, 3085, 3091, 3093, 2753, 2808, 2844, 2908, 2928, 2987, 3022, 3026, 3032, 3047, 3058, 2762, 2848, 2882, 2936, 2985, 3003, 3037, 3053, 3066, 3076, and 2872 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 4040 Nelson Ave Concord CA 94520-1200
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For Additional Information Contact |
925-246-8407
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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.
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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 |
143 units |
Distribution |
Worldwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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