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
    146386
  • Event Risk Class
    III
  • Event Initiated Date
    2016-09-12
  • 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
    When an roi with material override overlaps a fixation or support roi the material used for dose calculation in the overlapping region may not be as intended. also when a support or fixation roi overlaps the patient outline (external roi) in a dose grid voxel along the outer surface of the patient outline the density used for dose calculation in that voxel may not be as intended.

Device

RAYSTATION
  • Model / Serial
    Model Catalog: 2.5 (Lot serial: 4.7.1.10); Model Catalog: 4.7 (Lot serial: 4.7.0.15); Model Catalog: 4.5 (Lot serial: 4.7.0.15); Model Catalog: 4.0 (Lot serial: 4.7.0.15); Model Catalog: 3.0 (Lot serial: 4.7.0.15); Model Catalog: 2.5 (Lot serial: 4.7.0.15); Model Catalog: 4.7 (Lot serial: 4.5.2.7); Model Catalog: 4.5 (Lot serial: 4.5.2.7); Model Catalog: 4.0 (Lot serial: 4.5.2.7); Model Catalog: 3.0 (Lot serial: 4.5.2.7); Model Catalog: 2.5 (Lot serial: 4.5.2.7); Model Catalog: 4.7 (Lot serial: 4.5.1.14); Model Catalog: 4.5 (Lot serial: 4.5.1.14); Model Catalog: 4.0 (Lot serial: 4.5.1.14); Model Catalog: 3.0 (Lot serial: 4.5.1.14); Model Catalog: 2.5 (Lot serial: 4.5.1.14); Model Catalog: 4.7 (Lot serial: 4.5.0.19); Model Catalog: 4.5 (Lot serial: 4.5.0.19); Model Catalog: 4.0 (Lot serial: 4.5.0.19); Model Catalog: 3.0 (Lot serial: 4.5.0.19); Model Catalog: 2.5 (Lot serial: 4.5.0.19); Model Catalog: 4.7 (Lot serial: 4.0.3.4); Model Catalog: 4.5 (Lot serial: 4.0.3.4); Model Catalog: 4.0 (Lot serial: 4.0.3.4);
  • Product Description
    RAYSTATION
  • Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)

Manufacturer

RAYSEARCH LABORATORIES AB (PUBL)