Events

Recall of RAYSTATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RAYSEARCH LABORATORIES AB (PUBL).

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
    41339
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-23
  • 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
    Issue found with some of the tools used for drawing in and interacting with the patient views and beam's eye views. the issue concerns all tools that are used with the left mouse button held down. these tools can become unsynchronized with the stored data if other commands such as for example a right mouse click are used at the same time as the left mouse button is held down.

Device

RAYSTATION
  • Model / Serial
    Model Catalog: 4.0.3 (Lot serial: 4.5); Model Catalog: 4.7 (Lot serial: 4.5); Model Catalog: 4.0.3 (Lot serial: 4.7); Model Catalog: 4.7 (Lot serial: 4.7); Model Catalog: 4.7 (Lot serial: 4.0); Model Catalog: 4.7 (Lot serial: 3.0); Model Catalog: 4.0.3 (Lot serial: 3.5); Model Catalog: 4.7 (Lot serial: 3.5); Model Catalog: 4.0.3 (Lot serial: 4.0); Model Catalog: 4.0.3 (Lot serial: 3.0)
  • Product Description
    RAYSTATION
  • Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)

Manufacturer

RAYSEARCH LABORATORIES AB (PUBL)