Device Recall Siemens

  • Model / Serial
    IMMULITE 2000:  10380062, 10380061,10380079, 10380065, 10360210, 10283632  IMMULITE 2000XPi: P010053/S007;   10373214  VersaCell:   10380063, 10389945, 10380064, 10287115, 10793839
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Foreign Distribution.
  • Product Description
    IMMULITE 2000; IMMULITE 2000XPi; VersaCell || The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions Diagnostics, 62 Flanders-Bartley Rd, Flanders NJ 07836-4715
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

164 devices with a similar name

Learn more about the data here

  • Model / Serial
    Name and Model Number of device:  ARTISTE - 08139789  ONCOR Avant-garde - 05863472  ONCOR Impression Plus - 05857912 ONCOR Expression - 07360717 ONCOR Impression - 05857920 PRIUS HI - 04504200 Mevatron M2/Primus Mid-Energy 01940035  MEVATRON PRIMART - 05500371 MEVATRON KD-2 - 09822685 MEVATRON KDS-2 - 09411588 MEVATRON KDS-2 - 09822693 MEVATRON K2 - 08515520 MEVATRON 6323-2 - 01924500 MEVATRON M2 6740 - 09401506 MEVATRON M2 6700 - 09401407 MEVATRON 6300 - 09401316 MEVATRON MDX-2 - 09401746 MEVATRON MD-2 - 09401654 MEVATRON KD - 08319857 MEVATRON KDS - 09401522 MEVATRON 77 - 05659503 MEVATRON K7467 - 05694252 MEVATRON K7767 - 05694302 MEVATRON K8067 - 05694401 MEVATRON M 6300 (MX) - 08317000 MEVATRON M 6730 - 05694005 MEVATRON M 7140 - 05694104 MEVATRON M 7400 - 05694153 MEVATRON MDX - 08496200 MEVATRON MD (MD, MDX) - 08319808 MEVATRON M 7445 (MXE) - 05694203 MEVATRON M 7400/7440 (MXE) 05672977  MEVATRON M 6730/6740 (MXE) 08319758  MEVATRON M 6700 (MX) - 05693908  US Serial numbers:3397, 3986, 5087, 70-4119, 70-4144, 70-4262, 70-4343, 4078, 5120, 5170, 5282, 5506, 70-4146, 3287, 5527, 2958, 3855, 5517, 3753, 3702 3751 2863 3695 5364 3904 70-4287 70-4175 3102 3781 3203 5060 3798 70-4316 5205 3383 5688 5743 3832 2972 3942 70-4122 4067 70-4283 5190 5157 2646 5343 5844 3953 5148 5391 3931 5300 5300 3802 70-4172 70-4143 70-4296 3079 2516 70-4235 2962 70-4257 5474 2834 70-4363 70-4368 3791 3793 3738 3817 3055 5833 5899 2586 5207 3458 3673 70-4378 5355 3515 70-4159 3516 3524 3574 3519 5281 5894 5374 5558 1452 3225 2113 3631 3835 3367 3296 2702 3591 3267 2912 3905 3922 3924 2896 2814 3773 3679 3533 3709 5367 3618 70-4354 70-4356 5540 3103 5488 3859 3009 4019 5523 5590 5657 3624 2887 5350 5784 2974 5821 3503 70-4344 3285 3979 3541 3413 3774 2996 2125 5843 3504 3318 2628 70-4129 5851 3354 70-4183 3888 3066 3361 5098 3756 5385 2689 3305 2228 3604 3629 3136 5114 3748 3788 5700 2183 5410 2644 70-4323 3666 3825 2507 3241 70-4207 3987 4036 3989 5865 70-4166 3617 3736 1904 2279 5118 5548 3075 3769 2845 3842 5861 70-4188 5748 5222 2375 3013 3484 3302 3068 70-4317 5737 5830 2596 1897 5656 5245 5092 3303 3778 5088 4021 3245 5665 3815 3133 5823 3846 70-4178 2532 3907 70-4174 3534 5353 3826 3025 5630 70-4185 3639 3274 3664 2527 3761 5096 3801 3949 3878 3049 2894 5572 3699 3873 5417 4059 3805 5500 2965 5388 3547 2045 3116 3678 3186 70-4362 70-4379 5226 3623 3804 3453 3602 70-4142 2827 3657 3948 70-4135 3755 3754 5601 5640 3153 3622 5033 3514 5177 3084 3731 2855 4065 3147 5707 5398 4091 3644 4018 2906 5532 70-4306 70-4161 3114 3667 5424 3565 5755 3711 5326 5525 5145 3016 5699 4079 4082 70-4113 4015 3981 3057 5419 3998 3975 5093 3479 5481 5396 70-4347 2292 5008 2067 2818 3939 3089 5095 3901 5153 3244 5179 2244 5154 ROW Serial Numbers: 70-4217 3496 70-4221 70-4226 2801 2975 3312 3317 3389 3493 4045 70-4373 2495 2501 2551 2552 2559 2566 2619 2627 2674 2677 2682 2709 2728 2737 2741 2748 2755 2789 2809 2821 2822 2831 2852 2868 2879 2881 2884 2886 2895 2926 2946 2947 2953 2969 2971 2983 3006 3051 3054 3056 3063 3065 3083 3088 3096 3139 3152 3164 3166 3167 3169 3173 3178 3188 3194 3196 3197 3205 3221 3229 3247 3253 3275 3281 3282 3289 3293 3301 3306 3309 3313 3314 3321 3325 3328 3335 3338 3341 3358 3363 3368 3379 3388 3394 3404 3419 3432 3437 3446 3447 3449 3451 3457 3463 3472 3476 3478 3485 3487 3505 3508 3509 3523 3528 3535 3537 3538 3544 3546 3548 3554 3555 3559 3563 3566 3581 3585 3588 3589 3593 3596 3609 3611 3613 3615 3625 3627 3633 3635 3637 3643 3647 3652 3655 3656 3658 3659 3665 3671 3674 3676 3681 3682 3683 3687 3688 3694 3697 3712 3715 3716 3723 3726 3733 3741 3743 3765 3771 3775 3777 3779 3784 3785 3787 3789 3807 3809 3812 3834 3838 3843 3847 3849 3851 3854 3857 3864 3866 3869 3871 3874 3875 3879 3882 3885 3886 3889 3892 3898 3903 3906 3908 3911 3913 3914 3918 3921 3927 3928 3933 3935 3946 3951 3952 3966 3971 3992 3997 4003 4007 4014 4023 4025 4031 4034 4038 4041 4044 4046 4052 4054 4056 4058 4066 4073 4087 4092 4094 4215 4233 4236 4248 70-4088 70-4098 70-4104 70-4106 70-4108 70-4114 70-4115 70-4118 70-4121 70-4134 70-4138 70-4148 70-4151 70-4164 70-4181 70-4182 70-4191 70-4196 70-4199 70-4202 70-4203 70-4211 70-4214 70-4216 70-4228 70-4229 70-4242 70-4243 70-4245 70-4249 70-4254 70-4259 70-4261 70-4263 70-4265 70-4268 70-4273 70-4274 70-4284 70-4286 70-4293 70-4294 70-4298 70-4303 70-4304 70-4307 70-4321 70-4332 70-4339 70-4342 70-4352 70-4353 70-4358 70-4367 70-4369 70-4371 70-4372 70-4375 70-4377 70-4381 70-4382 70-4383 70-5005 70-5067 70-5231 2612 2726 2731 2769 3021 2782 2783 2797 2805 2808 2862 2883 2905 2918 2919 2923 2942 2944 2945 2957 2976 2978 2989 2992 3002 3003 3033 3034 3036 3043 3085 3091 3094 3095 3098 3119 3122 3123 3127 3129 3135 3143 3145 3146 3148 3149 3155 3157 3159 3172 3176 3182 3183 3184 3187 3189 3201 3227 3231 3233 3242 3250 3262 3265 3268 3279 3283 3288 3299 3307 3311 3315 3326 3327 3329 3332 3334 3336 3339 3347 3348 3366 3369 3372 3373 3382 3391 3395 3396 3401 3408 3416 3421 3431 3436 3438 3441 3454 3455 3459 3464 3466 3467 3468 3475 3481 3488 3489 3492 3506 3507 3513 3518 3521 3529 3531 3536 3539 3543 3549 3552 3553 3556 3558 3561 3573 3577 3582 3586 3594 3598 3599 3606 3612 3621 3632 3636 3641 3642 3645 3646 3653 3654 3661 3662 3668 3669 3677 3684 3686 3689 3703 3704 3708 3713 3714 3719 3722 3724 3725 3734 3735 3749 3752 3757 3759 3762 3763 3766 3768 3772 3782 3786 3813 3814 3818 3819 3822 3824 3831 3833 3839 3844 3853 3861 3867 3868 3872 3876 3893 3902 3909 3915 3917 3919 3936 3943 3947 3958 3959 3961 3967 3969 3972 3976 3984 3985 3991 3993 3994 3995 3999 4004 4006 4013 4028 4033 4039 4042 4043 4047 4051 4055 4057 4061 4075 4076 4085 4086 4099 4105 4131 4218 4232 4239 70-3608 70-4101 70-4102 70-4103 70-4112 70-4116 70-4126 70-4133 70-4139 70-4141 70-4156 70-4162 70-4187 70-4192 70-4194 70-4195 70-4198 70-4204 70-4205 70-4206 70-4208 70-4212 70-4219 70-4225 70-4234 70-4237 70-4247 70-4251 70-4255 70-4256 70-4264 70-4266 70-4271 70-4275 70-4279 70-4282 70-4285 70-4302 70-4308 70-4315 70-4318 70-4322 70-4326 70-4327 70-4341 70-4351 70-4357 70-4364 70-4376 3603 1444 1448 1473 1695 1397 2025 2032 2198 2212 2225 2022 3776 3795 3799 3808 3823 3841 3848 3858 3863 3916 3925 3954 3955 3963 3965 3968 3983 4002 4008 4009 4011 4017 4022 4024 4027 4037 4062 4064 4068 4071 4074 4081 4084 4096 70-4093 70-4097 70-4107 70-4123 70-4124 70-4127 70-4132 70-4136 70-4137 70-4149 70-4153 70-4158 70-4171 70-4176 70-4189 70-4193 70-4209 70-4215 70-4224 70-4231 70-4253 70-4272 70-4278 70-4288 70-4292 70-4295 70-4299 70-4301 70-4305 70-4328 70-4329 70-4331 70-4334 70-4335 70-4338 70-4346 70-4348 70-4361 70-4365 70-4366 70-4384 3811 3883 3894 3962 3973 3974 4048 70-4083 70-4152 70-4165 70-4167 70-4238 70-4276 70-4277 70-4281 70-4374 3737 3739 3758 3806 3852 3856 3884 3891 3895 3912 3929 3932 3937 70-4163 70-4184 70-4213 70-4223 70-4297 70-4311 70-4314 1926 2472 2563 2609 2617 2639 2659 2742 2771 2837 2885 2429 2651 2752 2849 2331 2591 2633 2654 2766 2889 2939 2943 2163 2346 2685 2716 2747 2812 2813 2825 2856 2874 2584 2485 2673 3308 3578 340180 2788 2703 2445
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including Canada and Mexico.
  • Product Description
    Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2, MEVATRON KD, MEVATRON KDS, MEVATRON 77, MEVATRON K7467, MEVATRON 7767, MEVATRON K8067, MEVATRON M 6300 (MX), MEVATRON M 6730, MEVATRON M 7140, MEVATRON M 7400, MEVATRON MDX, MEVATRON MD (MD, MDX), MEVATRON M 7445 (MXE), MEVATRON M 7400/7440 (MXE), MEVATRON M 6730/6740 (MXE), MEVATRON M 6700 (MX): the intended use of the MEVATRON , PRIMUS , ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
  • Manufacturer
  • Model / Serial
    All serial numbers.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.
  • Product Description
    RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. || These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.
  • Manufacturer
  • Model / Serial
    All serial numbers.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.
  • Product Description
    RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. || The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.
  • Manufacturer
  • Model / Serial
    All serial numbers.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.
  • Product Description
    RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. || The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
  • Manufacturer
  • Model / Serial
    All serial numbers.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.
  • Product Description
    RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. || The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
  • Manufacturer
159 more