Events

Recall of HEXAPOD EVO-RT-COUCHTOP

According to Health Canada (via FOI), this recall involved a device in Canada 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
    122291
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The hexapod evo module is fixed to the base table with six screws. if the screws are not properly tightened during installation the screws may become loose over time. if the screws become loose there is a potential that the patient could fall off the couchtop.

Device

HEXAPOD EVO-RT-COUCHTOP
  • Model / Serial
    Model Catalog: P10603-700 (Lot serial: >10 contact Mfr)
  • Product Description
    HEXAPOD EVO-RT-COUCHTOP
  • Manufacturer
    ELEKTA INC.

Manufacturer

ELEKTA INC.
  • Manufacturer Address
    ATLANTA
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC