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U.S. Department of Health and Human Services

Class 2 Device Recall Mevatron/ PRIMUS Medical Linear Accelerator

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  Class 2 Device Recall Mevatron/ PRIMUS Medical Linear Accelerator see related information
Date Initiated by Firm January 11, 2008
Date Posted April 02, 2008
Recall Status1 Terminated 3 on May 06, 2011
Recall Number Z-1394-2008
Recall Event ID 46940
510(K)Number K993525  
Product Classification Medical Linear Accelerator - Product Code IYE
Product Mevatron M2/PRIMUS MID Medical Linear Accelerator, Material Number: 019490035, 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
Code Information Serial Numbers: 3978 70-4188 3016 3512 3208 3873 2767 2792 2855 2959 3133 3162 3228 3296 3364 3439 3482 3702 3788 3986 3616 2526 2758 2847 3009 3103 3435 3541 3859 3931 3433 3805 3842 3618 70-4287 3055 3678 3495 3798 3258 3285 3294 3617 3736 3425 3748 70-4146 3084 2961 2955 70-4363 3383 2596 3089 3274 3448 2784 3316 3604 3629 3639 4018 5092 2722 2834 3756 2968 3353 3605 70-4316 2738 2845 2965 3136 5114 70-4323 2816 2913 3243 3138 3826 2901 3624 3699 2806 2875 3774 3557 2765 3303 3623 70-4178 3156 3458 3673 3246 3251 3491 3108 3857 3903 3911 3376 4063 2803 2804 3321 3394 3923 2673 2748 2822 2881 2953 2984 3015 3197 3314 3328 3363 3415 3885 3726 3869 3928 3196 3198 3252 3344 3508 3532 3563 3637 3874 4014 4023 4025 5009 5019 5051 5070 70-4104 70-4191 70-4261 70-4375 3388 4087 3352 3607 3613 3687 3849 3851 3921 3935 3992 4044 5075 5078 5106 5107 5111 70-4199 70-4211 70-4245 70-4259 70-4265 70-4286 70-4293 70-4294 70-4321 70-4337 70-4353 70-4355 70-4377 70-4382 70-4385 3659 3271 3551 3707 5067 70-4249 70-4254 70-4367 2895 3765 3566 70-4304 3374 3428 3445 3498 4056 5052 70-4182 3914 2947 3449 3293 3546 5071 70-4242 3496 and 5109
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact
925-246-8407
Manufacturer Reason
for Recall		 Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
FDA Determined
Cause 2		 Software design
Action This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it.
Quantity in Commerce 896 units
Distribution 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
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.
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