Events

Recall of XVI (X-RAY VOLUME IMAGING SYSTEM)

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
    15514
  • Event Risk Class
    II
  • Event Initiated Date
    2013-12-20
  • 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
    Erroneous asu table move in height direction may cause a collision when an external beam limiting device (bld) (i.E apex) is used.

Device

XVI (X-RAY VOLUME IMAGING SYSTEM)
  • Model / Serial
    Model Catalog: MRT 9271 (Lot serial: VER. R4.2.1); Model Catalog: MRT9451 (Lot serial: VER. R4.2.1); Model Catalog: MRT 9451 (Lot serial: VER. R5.0); Model Catalog: MRT 14931 (Lot serial: VER. R5.0); Model Catalog: MRT 14921 (Lot serial: VER. R5.0); Model Catalog: MRT 9451 (Lot serial: VER. R4.5.1); Model Catalog: MRT 14931 (Lot serial: VER. R4.5.1); Model Catalog: MRT 13221 (Lot serial: VER. R4.5); Model Catalog: MRT 9451 (Lot serial: VER. R4.5); Model Catalog: MRT 14931 (Lot serial: VER. R4.5); Model Catalog: MRT 14921 (Lot serial: VER. R4.5); Model Catalog: MRT 13221 (Lot serial: VER. R5.0); Model Catalog: MRT 13221 (Lot serial: VER. R4.5.1); Model Catalog: MRT 14921 (Lot serial: VER. R4.5.1)
  • Product Description
    XVI (X-RAY VOLUME IMAGING SYSTEM)
  • Manufacturer
    ELEKTA INC.

Manufacturer

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