PRIMUS Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 4504200,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

This recall has been terminated (originally issued November 9, 2007).

Company: Siemens Medical Solutions Usa, Inc
Recall Initiated: March 22, 2007
Posted: November 9, 2007
Terminated: December 18, 2010
Recall Number: Z-0169-2008
Quantity: 687 units
Firm Location: Concord, CA
Official Source: View on FDA website ↗

Reason for Recall

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

Distribution

Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia

AK AL AR AZ CA CO DC DE FL GA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NV NY OH OK OR PA PR RI SC SD TN TX VA VT WA WI WY

Lot / Code Info

MODEL NUMBER: 4504200; Serial Numbers: 2701, 2733, 2762, 2768, 2823, 2827, 2828, 2836, 2839, 2842, 2846, 2848, 2863, 2867, 2887, 2893, 2894, 2896, 2899, 2911, 2912, 2914, 2931, 2933, 2934, 2936, 2941, 2954, 2958, 2972, 2991, 2996, 2997, 3004, 3014, 3019, 3025, 3027, 3039, 3049, 3053, 3066, 3068, 3069, 3075, 3076, 3077, 3079, 3087, 3092, 3097, 3102, 3105, 3109, 3111, 3112, 3114, 3125, 3131, 3134, 3137, 3142, 3153, 3154, 3161, 3165, 3168, 3174, 3179, 3181, 3186, 3203, 3209, 3211, 3212, 3213, 3214, 3215, 3223, 3224, 3225, 3239, 3241, 3244, 3245, 3254, 3255, 3257, 3261, 3264, 3267, 3272, 3286, 3292, 3297, 3302, 3305, 3318, 3319, 3323, 3324, 3342, 3349, 3354, 3361, 3365, 3367, 3377, 3392, 3402, 3403, 3413, 3414, 3417, 3418, 3422, 3423, 3424, 3426, 3427, 3443, 3452, 3453, 3456, 3461, 3471, 3474, 3477, 3479, 3484, 3501, 3504, 3514, 3515, 3516, 3519, 3524, 3533, 3534, 3542, 3547, 3564, 3565, 3568, 3569, 3572, 3574, 3583, 3595, 3597, 3601, 3602, 3622, 3634, 3651, 3657, 3666, 3667, 3672, 3675, 3679, 3695, 3696, 3701, 3709, 3711, 3731, 3745, 3751, 3773, 3781, 3825, 3829, 3832, 3835, 3862, 3899, 3922, 3924, 3942, 3949, 3978, 3979, 4001, 4036, 4059, 5008, 50941, 2933A, 70-4117, 70-4185, 3744, 3749, 340258, 340262, 2956, 2963, 3579, 3582, 3587, 3592, 3663, 2773, 2815, 2964, 3046, 3217, 3308, 3334, 3724, 3917, 3598, 3752, 3373, 3561, 104744, 3042, 3158, 3191, 3284, 3291, 3295, 3356, 3378, 3382, 3406, 3407, 3469, 3619, 3638, 3641, 3645, 3742, 3919, 70-4173, 3612, 3824, 3995, 3732, 2869, 3219, 3343, 3502, 3861, 2871, 3268, 70-4126, 2753, 2808, 2928, 2987, 3026, 3032, 3037, 3047, 3117, 3201, 3234, 3346, 3398, 3431, 3522, 3545, 3599, 3649, 3703, 3704, 3767, 3814, 5063, 2782, 2783, 2796, 2829, 2832, 2833, 2851, 2854, 2866, 2891, 2938, 2942, 2944, 2945, 2948, 2967, 2973, 2989, 2994, 3031, 3033, 3034, 3044, 3072, 3081, 3091, 3093, 3094, 3098, 3106, 3127, 3128, 3129, 3144, 3145, 3155, 3182, 3199, 3231, 3259, 3332, 3333, 3348, 3351, 3362, 3387, 3399, 3438, 3467, 3539, 3549, 3552, 3578, 3614, 3686, 3693, 3763, 4013, 2957, 3307, 3395, 3444, 3936, 2862, 2976, 3642, 3833, 4099, 4131, 4232, 70-4131, 70-4308, 2793, 2805, 2918, 3202, 3499, 3571, 3577, 3684, 3714, 3718, 3725, 3768, 3786, 3794, 3958, 3972, 3977, 3999, 4042, 4075, 5073, 98943, 102842, 340274, 70-4264, 70-4194, 3311, 3369, 3401, 2785, 2992, 3107, 3135, 3183, 3326, 3372, 3396, 3408, 3416, 3421, 3475, 3689, 3961, 4039, 5036, 70-4133, 70-4271, ZTVK00010, 104, 2844, 2908, 3022, 3058, 3143, 3148, 3157, 3184, 3187, 3189, 3193, 3233, 3237, 3256, 3262, 3278, 3315, 3327, 3336, 3359, 3366, 3436, 3488, 3513, 3518, 3521, 3526, 3529, 3531, 3536, 3668, 3677, 3717, 3813, 3819, 3822, 3839, 3844, 3867, 3868, 3872, 3876, 3902, 3943, 3984, 3985, 3991, 4033, 4043, 4047, 4055, 4057, 4085, 4105, 5007, 5010, 5021, 5050, 5066, 5079, 5090, 70-4101, 70-4102, 70-4187, 70-4204, 70-4206, 70-4219, 70-4225, 70-4227, 70-4247, 70-4252, 70-4266, 70-4275, 70-4351, 70-4357, 70-4364, 3250, 4103, 70-4103, 3288, 2975, 3227, 3339, 3347, 3386, 3389, 3994, 4045, 70-4373, 3028, 3722, 4061, 70-4195, 344125, 2985, 3011, 3483, 3506, 3562, 3698, 3412, 3002, 3273, 3276, 3489, 3492, 2916, 2917, 2922, 2978, 2979, 3005, 3007, 3067, 3085, 3115, 3119, 3149, 3176, 3248, 3265, 3299, 3455, 3459, 3462, 3464, 3468, 3511, 3558, 3573, 3586, 3632, 3646, 3669, 3762, 3766, 3782, 3818, 3831, 3853, 3915, 3947, 3959, 3976, 3993, 4051, 4076, 4239, 5047, 340203, 70-4116, 70-4156, 70-4162, 70-4198, 70-4205, 70-4208, 70-4212, 70-4237, 70-4255, 70-4279, 70-4315, 70-4318, 70-4322, 70-4326, 70-4341, 70-4376, 3043, 3594, 340180, 3746, 340263, 3384, 3146, 3283, 70-4282, 2897, 2902, 2904, 2993, 3249, 3626, 3628, 3893, 4004, 3727, 3728, 3441, 70-4327, 2905, 3121, 3123, 3177, 3216, 3584, 3757, 3828, 3312, 3317, 2882, 3279, 3734, 4218, 70-4218, 2924, 3024, 3606, 3608, 3909, 70-4139, 70-4141, 70-4251, 2797, 2883, 2903, 2919, 2923, 2986, 3036, 3095, 3122, 3159, 3172, 3242, 3391, 3454, 3466, 3543, 3553, 3556, 3621, 3636, 3653, 3654, 3661, 3662, 3713, 3772, 3967, 3969, 4006, 4028, 4109, 5045, 5046, 70-4112, 70-4192, 70-4285, 2878, 3017, 3329, 2872, 2966, 3064, 3797, 3897, 5013, 2892, 3008, 3074, 3218, 3226, 3375, 3486, 3567, 3493, 3003, 3507, 3735, 3759, 4086, 5003, 340264, 70-4256, 3113, 3238, 3405, 3465, 3481, 3691, 3706, 3708, 3719, 3721, 340251, 298700097, 302600003, 303200005, 303700007, 304700009, 311700023, 334600031, 3411, 3887, 3525, 3544, 70-4302.

Root Cause

Software design

Action Taken

Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment. Current control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during "Service Mode."