Events

Recall of Device Recall Leksell Gamma Knife Perfexion

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
    54554
  • Event Risk Class
    Class 2
  • Event Number
    Z-1158-2010
  • Event Initiated Date
    2007-07-02
  • Event Date Posted
    2010-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88709
  • 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
    Radionuclide Radiation Therapy System - Product Code IWB
  • Reason
    Need to modify the closing speed of the shielding doors in the event of an emergency exit.
  • Action
    A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.

Device

Device Recall Leksell Gamma Knife Perfexion
  • Model / Serial
    Serial Numbers: 6002, 6003, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, and 6030.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.
  • Product Description
    Leksell Gamma Knife Perfexion, Article #715000. || Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
  • 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