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U.S. Department of Health and Human Services

Class 2 Device Recall LINAC Accelerators

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  Class 2 Device Recall LINAC Accelerators see related information
Date Initiated by Firm December 19, 2014
Date Posted February 05, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-1059-2015
Recall Event ID 70138
510(K)Number K072485  K031764  K060226  K993425  K982502  
Product Classification Accelerator, linear, medical - Product Code IYE
Product LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI,
Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2,
MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2,
MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; 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.

Product Usage: 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.
Code Information model numbers: 08139789, 05863472, 05857912, 07360717, 05857920, 04504200, 01940035, 05500371,  09822685, 09411588, 09822693, 08515520, 01940753, 01924500, 09401506, 09401407, 09401316, 09401746, 09401654, with serial numbers: 3397 3986 5087 70-4119 70-4144 70-4262 70-4343 4078 5120 5170 5282 5506 70-4146 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 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 3524 3574 3519 5281 5894 5374 5558 3225 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 5118 5548 3075 3769 2845 3842 5861 70-4188 5748 5222 3013 3484 3302 3068 70-4317 5737 5830 2596 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 5419 3998 3975 5093 3479 5481 5396 70-4347 5008 2067 2818 3939 3089 5095 3901 5153 3244 5179 2244 5154 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission.
FDA Determined
Cause 2		 Component design/selection
Action Siemens sent a Customer Advisory Notice Letter TH016/14/S, dated December 19, 2014, to end users that identified the product, problem, and actions to be taken. End users were advised to read the Field Safety Notice and include it with the User's Manual until the hardware update is completed.
Quantity in Commerce 310
Distribution Worldwide Distribution - US Nationwide including Canada and Mexico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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