Events

Recall of Device Recall Leksell Gamma Knife.

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
    55001
  • Event Risk Class
    Class 2
  • Event Number
    Z-1236-2010
  • Event Initiated Date
    2007-10-01
  • Event Date Posted
    2010-04-13
  • 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=89656
  • 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
    Gamma Knife (Radionuclide radiation therapy system) - Product Code IWB
  • Reason
    After updating the lgk actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator.
  • Action
    Field Change Order 0000203 "Replacement of obsolete actuator sleigh on Helmet Changer", was sent to all customers that were affected. Direct questions to Elekta, Inc. by calling 1-770-670-2548.

Device

Device Recall Leksell Gamma Knife.
  • Model / Serial
    LGK 4203, LGK 4309, LGK 4333, LGK 4343 and LGK 4354.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States (CA, TN, TX and WA) and Taiwan.
  • Product Description
    Leksell Gamma Knife. || Leksell Gamma Knife is a teletherapy device 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