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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 Device Recall Mevatron M2 PRIMUS midenergy see related information
Date Initiated by Firm August 07, 2007
Date Posting Updated 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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