Events

Recall of Device Recall Mevatron/ PRIMUS Medical Linear Accelerator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46940
  • Event Risk Class
    Class 2
  • Event Number
    Z-1394-2008
  • Event Initiated Date
    2008-01-11
  • Event Date Posted
    2008-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69040
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Medical Linear Accelerator - Product Code IYE
  • Reason
    Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
  • 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.

Device

Device Recall Mevatron/ PRIMUS Medical Linear Accelerator
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    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
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA