Events

Recall of ARTISTE, ONCOR, MEVATRON, and PRIMUS Digital Linear Accelerators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510.

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
    56773
  • Event Risk Class
    Class 2
  • Event Number
    Z-0907-2011
  • Event Initiated Date
    2010-08-13
  • Event Date Posted
    2011-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94518
  • 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
    Linear Medical Accelerator - Product Code IYE
  • Reason
    The potential safety issue with the 160mlc or the hpd collimator of mechanical noises and/or sticking of the collimator when rotating the collimator. the potential for mistreatment to a patient should the collimator not be aligned correctly if the bearings are damaged.
  • Action
    Urgent: Medical Device Correction Safety Advisory Notice letters were sent by certified mail commencing August 3, 2010. The letter described the issue and when it occurs, the measures users could take, and how Siemens would address the issue. It is recommended that customers include a check of the field alignment at 90 and 270 degrees gantry angle in the daily check prior to start of patient treatments. A copy of the Safety Advisory Notice should be included in the Owner's Manual and questions should be directed towards the local Siemens Service Engineer or Application Specialist.

Device

ARTISTE, ONCOR, MEVATRON, and PRIMUS Digital Linear Accelerators
  • Model / Serial
    All units of these models.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA; || Intended to deliver x-ray radiation for therapeutic treatment of cancer. || ARTISTE with 160 MLC, Part No.8139789, || ONCOR AG with 160 MLC, Part No.5863472 || ONCOR Impression || Plus with 160 MLC, Part No.5857912, || ONCOR Expression with 160 MLC, Part No.7360204, || ONCOR Expression with 160 MLC, Part No.7360717, || PRIMUS HI with HPD, Part No. 4504200, || MEVATRON M2 / PRIMUS Mid-Energy / HPD, Part No.1940035, || MEVATRON 6323-2 / HPD, Part No.19244500, || MEVATRON K2 / HPD, Part No.1940753, || MEVATRON PRIMART / HPD, Part No.5500371, || MEVATRON 77 / HPD, Part No.5659503, || MEVATRON M 7400 / 7440 (MEX) / HPD, Part No.5672977, || MEVATRON M 6700 (MX) / HPD, Part No.5693908, || MEVATRON M 6730 / HPD, Part No.5694005, || MEVATRON M 7140 / HPD, Part No.5694104, || MEVATRON M 7400 / HPD, Part No.5694153, || MEVATRON M 7445 / HPD (MEX), Part No.5694203, || MEVATRON K 7467 / HPD, Part No.5694252, || MEVATRON K 7767 / HPD, Part No.5694302, || MEVATRON K 8067 / HPD, Part No.5694401, || MEVATRON M 6300 (MX) / HPD, Part No.8317000, || MEVATRON M 6730/6740 (MEX) / HPD, Part No.8319758, || MEVATRON MD (MD, MDX) / HPD, Part No.8319808, || MEVATRON KD / HPD, Part No.8319857, || MEVATRON MDX / HPD, Part No.8496200, || MEVATRON KD-2 / HPD, Part No.8515520, || MEVATRON M3 6300 / HPD, Part No.9401316, || MEVATRON M2 6700 / HPD, Part No.9401407, || MEVATRON M2 6740 / HPD, Part No.9401506, || MEVATRON KDS / HPD, Part No.941522, || MEVATRON MD-2 / HPD, Part No.9401654, || MEVATRON MDX  2 / HPD, Part No.9401746, || MEVATRON KDS-2 / HPD, Part No.9411588, || MEVATRON KD-2 / HPD, Part No.9822685, || MEVATRON KDS-2 / HPD, Part No.9822693
  • Manufacturer
    Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510

Manufacturer

Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510
  • Manufacturer Address
    Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510, 4040 Nelson Ave, Concord CA 94520-1200
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA