Events

Recall of XVI R4.5 (X-RAY VOLUME IMAGING SYSTEM)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA LIMITED.

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
    15963
  • Event Risk Class
    II
  • Event Initiated Date
    2011-10-24
  • 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
    If you make a correction where you move the clip/mask slider in the clipbox it can move the critical structures in an incorrect direction. this only occurs if there is a large rotation in the clipbox registration. elekta recommends to do an image review to make sure that the end result is correct. if error not seen and treatment table correction has been applied it can cause clinical mistreatment.

Device

XVI R4.5 (X-RAY VOLUME IMAGING SYSTEM)
  • Model / Serial
    Model Catalog: MRT 14921 (Lot serial: all affected xvi 4.5)
  • Product Description
    Synergy xvi
  • Manufacturer
    ELEKTA LIMITED

Manufacturer

ELEKTA LIMITED
  • Manufacturer Address
    CRAWLEY
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC