Device Recall PRIMUS Plus

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.

Radiology Devices

2

No

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

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

Serial Numbers: 3479 70-4347 3014 3574 2972 3365 3377 3564 2828 3942 3102 2941 3212 3215 3286 3305 3324 3342 3354 3418 3595 3667 4059 3272 3899 2839 2991 3154 3533 3572 3583 3679 3862 3922 3924 4036 2914 3168 3474 3542 3027 3153 3255 3318 3514 3622 3672 3675 3835 3423 3244 3524 3602 3696 3403 3471 3979 2911 3019 3114 3213 3049 3174 3179 3257 3731 3773 3832 3949 2996 3701 2836 2867 3087 3597 3068 3223 3601 2931 3484 2827 3075 3077 3142 3264 3427 3461 3519 3657 3004 3477 3547 2896 3112 3211 3651 3711 3745 4001 3105 3137 2934 3131 3186 3323 3417 3568 3292 2863 2894 3125 3134 3319 3349 3414 3504 3634 3695 3781 2768 3666 3825 3452 2701 2933 3039 3092 3402 3426 3569 2893 3069 3111 3079 3181 3565 70-4185 3239 3515 3516 3453 2899 3214 3751 2823 2846 2954 3456 3709 3203 3424 3245 3443 2912 2958 3261 3267 3297 3392 3413 3534 3241 3224 3829 2887 3011 2733 3727 3728 2956 2963 3579 3582 3663 2815 2964 3046 3217 3308 3724 3752 3042 3158 3191 3284 3291 3295 3356 3378 3382 3406 3407 3619 3638 3641 3645 3742 3919 70-4173 3612 3824 3995 2869 3219 3343 3502 2753 2987 3398 3522 3814 2782 2783 2796 2829 2832 2833 2938 2944 2945 2948 2973 2994 3033 3034 3072 3098 3106 3128 3144 3333 3348 3351 3362 3387 3399 3438 3467 3539 3549 3614 3693 4013 3444 3936 3499 3577 3725 3786 3794 3977 4042 2785 3408 3421 3475 4039 5036 70-4271 2844 3148 3189 3237 3262 3278 3336 3359 3436 3488 3529 3531 3677 3717 3813 3822 3839 3844 3867 3868 3872 3876 3902 3943 3985 3991 4033 4043 4047 4055 4057 4085 5010 5021 5050 5066 5077 5079 70-4102 70-4206 70-4219 70-4225 70-4247 70-4252 70-4275 70-4351 70-4364 70-4103 3347 3386 3389 3994 4045 3028 3722 70-4195 3483 3506 3562 3698 3489 3492 3248 3299 3455 3468 3646 3669 3762 3831 3915 3947 3976 5043 5047 5076 70-4116 70-4162 70-4198 70-4212 70-4237 70-4255 70-4279 70-4315 70-4318 70-4322 70-4341 70-4376 3594 3746 3384 3283 70-4282 3893 4004 3123 3216 3584 3734 2924 3024 3606 3608 3909 70-4139 70-4141 70-4251 2883 2986 3036 3095 3159 3242 3391 3454 3543 3553 3556 3621 3636 3653 3654 3661 3662 3772 3967 3969 4006 4028 5045 5046 70-4112 70-4192 70-4285 3017 2966 3064 3797 3008 3218 3375 3567 5097 3507 3759 4086 5003 5110 70-4256 3288 3113 3238 3405 3481 3691 3706 3708 3721 70-4302 3587 3592 3732 3861 70-4126 3767 3231 3332 3578 3686 3833 70-4308 3999 3369 3401 3412 3002 3273 3276 3005 3462 4076 2878 3329 3897 3493 3465 and 3719

Radiology Devices

2

No

Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa Rica, Croatia,Cyprus,The Czech Republic,Denmark,DPR of Korea,El Salvador,France,Germany,Greece,Hungary,India,Iran,Ireland,Italy,Japan,Jordan,Malaysia,Mexico, The Netherlands,New Zealand,Norway,P.R. China,Pakistan,Peru,Philippines,Poland,Portugal,Republic of Korea,Romania,Russian Fed.Saudi Arabia,Singapore,Slovakia,South Africa,Spain,Sweden,Taiwan,Thailand,Trinidad,Tobago,Turkey, U.A.E.,Ukraine, The United Kingdom, and Venezuela

Primus Plus Medical Linear Accelerator, Material Number : 4504200, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA