Recall of Mevatron KDS2

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Incorrect field size -- products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. this problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.
  • Action
    The firm has sent consignees a Customer Safety Advisory Notice on August 7, 2007 informing them that a misplacement of the X and/or Y jaws can occur if interlock #51 Jaw Field Position is asserted and then cleared with the left-hand key rest. The firm recommends that if an interlock issue is encountered tha treatment of the patient be discontined until this issue is resolved.


  • Model / Serial
    Serial Numbers: 2108, 2183, 2244, 2251, 2263, 2272, 2284, 2289, 2335, 2357, 2084, 2168, 2264, 2304, 2394, 2398, 2023, 2055, 2097, 2106, 2122, 2158, 2208, 2222, 2242, 2269, 2276, 2324, 2336, 2339, 2353, 2358, 2372, 2196, 2229
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution
  • Product Description
    Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9822693 and 9411588, Siemens Medical Solutions, Concord, CA 94520
  • Manufacturer


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