Events

Recall of Device Recall Radionuclide Radiation Therapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, 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
    54886
  • Event Risk Class
    Class 2
  • Event Number
    Z-1231-2010
  • Event Initiated Date
    2007-05-30
  • Event Date Posted
    2010-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89377
  • 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
    System, radiation therapy, radionuclide - Product Code IWB
  • Reason
    There has been an issue with "image fushing" where low precision calculation caused images to become inaccurate.
  • Action
    Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725.

Device

Device Recall Radionuclide Radiation Therapy System
  • Model / Serial
    Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.
  • Product Description
    Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. || Indicated for use in the stereotactic irradiation of intracranial structures.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA