Events

Recall of Device Recall MEVATRON KD2

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
    76459
  • Event Risk Class
    Class 2
  • Event Number
    Z-1437-2017
  • Event Initiated Date
    2017-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153264
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Siemens became aware of a defective weld seam at overhead suspensions. due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. this can lead to a severe injury to a patient or any other person.
  • Action
    Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.

Device

Device Recall MEVATRON KD2
  • Model / Serial
    Device Model Number 8515520 Serial numbers: 3009 2958 2863 2972 2646 3079 2516 2962 3055 1452 2702 2125 3066 2689 2228 2564 2507 1904 3075 2375 3013 3068 2596 3025 3049 2965 2045 3084 2855 2906 2292 2384 2067 2818 3089
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    MEVATRON KD-2, accelerator, Linear, Medical || The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA