Events

Recall of XVI R4.5 SYSTEM - UPGRADE KIT XVI R4.5

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
    143043
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-11
  • 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 another patient is selected on the imaging system (xvi release 4.5) during the transmission of end of treatment data from destop pro r7.01 to r&v system the xvi information is prioritized and the end of treatment data is never received by the r&v system. this leads to a potentially misleading dialogue on the r&v system that may result in a re-treat of field just completed.

Device

XVI R4.5 SYSTEM - UPGRADE KIT XVI R4.5
  • Model / Serial
    Model Catalog: MRT 13221 (Lot serial: 151940); Model Catalog: MRT 13221 (Lot serial: 105871); Model Catalog: MRT 13221 (Lot serial: 152164); Model Catalog: MRT 13221 (Lot serial: 152159); Model Catalog: MRT 13221 (Lot serial: 152160)
  • Product Description
    ELEKTA SYNERGY XVI R4.5 - mrt13221
  • Manufacturer
    ELEKTA INC.

Manufacturer

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