Events

Recall of ALIGNRT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VISION RT 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
    48885
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-01
  • 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
    Vision rt has been notified that unintended changes can be made to planned couch parameters specifically the couch rotation parameter during patient set-up. this can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with vision rt's alignrt device prior to treatment with varian's truebeam radiotherapy delivery system [truebeam]. neither vision rt nor varian received any report of patient harm due to this issue.

Device

ALIGNRT
  • Model / Serial
    Model Catalog: ALIGNRT (Lot serial: 249-1519)
  • Product Description
    ALIGNRT
  • Manufacturer
    VISION RT LIMITED

Manufacturer

VISION RT LIMITED