{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Malvern", "address_1": "51 Valley Stream Pkwy", "reason_for_recall": "Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose calculation, or an overdose and serious injury may occur.", "address_2": "", "product_quantity": "320", "code_info": "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 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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", "center_classification_date": "20150115", "distribution_pattern": "Worldwide Distribution - US Nationwide including Canada and Mexico.", "state": "PA", "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.", "report_date": "20150121", "classification": "Class II", "openfda": {}, "recalling_firm": "Siemens Medical Solutions USA, Inc", "recall_number": "Z-0980-2015", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "69956", "termination_date": "20150512", "more_code_info": "", "recall_initiation_date": "20141202", "postal_code": "19355-1406", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }