FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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
- Recall number
- Z-0687-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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
- Status
- Terminated
- Initiated
- 2007-08-07
- Posted
- 2008-02-14
- Terminated
- 2010-12-01
- Reason
- 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.
- Root cause
- 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
- 143 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K993425"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28