Events

Recall of Device Recall HexaPOD evo RT 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
    74967
  • Event Risk Class
    Class 2
  • Event Number
    Z-2691-2016
  • Event Initiated Date
    2016-08-18
  • Event Date Posted
    2016-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148905
  • 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
    Potentially unrecognized incorrect position of the treatment couch in 3d workflow, i.E. the hexapod has not moved fully to the 3d position.
  • Action
    Elekta sent an Important User Notice 618-03-303-025 to affected customers on 8/18/2016. The notice identified the affected product, problem, clinical impact, solution and actions to be taken. The Notice reminds users that the Interlock Check is not possible during 3D Workflow as iGUIDE is not in use. The notice reminds users that if iGUIDE is not being used - (A) Ensure the HexaPOD is at its pre-defined 3D position before treatment, and (B) Ensure the External Inhibit LED at the EnableSwitch Board is off. For questions contact your local Elekta office.

Device

Device Recall HexaPOD evo RT System
  • Model / Serial
    iGuide 2.2.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
  • Product Description
    HexaPOD evo RT System || Product Usage: || The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA