Events

Recall of RaySearch RayStation Radiation therapy treatment planning system 4.0

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by RaySearch Laboratories AB.

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
    16598
  • Event Initiated Date
    2014-04-30
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • Reason
    There is a potential problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi (region of interest) can be wrong. this affects all dose-volume properties for such rois, including dvh (dose-volume histogram), dose statistics, clinical goals and constraints or objective functions. furthermore, if material override rois are used, or if the external is not represented by contours, the bug can trigger an error in the 3d dose distribution.
  • Action
    Software to be upgraded

Device

RaySearch RayStation Radiation therapy treatment planning system 4.0

Manufacturer

RaySearch Laboratories AB