Events

Recall of Device Recall Elekta Leksell Gamma

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
    60125
  • Event Risk Class
    Class 2
  • Event Number
    Z-0307-2012
  • Event Initiated Date
    2011-06-23
  • Event Date Posted
    2011-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104476
  • 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 is a risk that the user may interpret the instructions in the manual too literally, and adjust the tmr 10 dose description to obtain an etcpd that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.
  • Action
    Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.

Device

Device Recall Elekta Leksell Gamma
  • Model / Serial
    6107 and 6115
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) - including the states of: NM and WA
  • Product Description
    Elekta Leksell Gamma Plan || Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.
  • 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