Events

Recall of Raystation RaySearch treatment planning system

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
    16238
  • Event Initiated Date
    2014-02-17
  • 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
    The rotation component of the rigid registration computed prior to the deformable registration is not accounted for in fusion views when mapping structures (regions or points of interest) or when deforming dose. since the error affects all applications of the hybrid deformation, its effect on the above functions is displayed in the user interface. at that time the user would be able to view the result and evaluate the quality of the deformation and identify any potential errors in the results.
  • Action
    Software to be upgraded

Device

Raystation RaySearch treatment planning system
  • Model / Serial
    Model: , Affected: , Software version: Versions: 2.5, 3.0, 3.5 and 4.0
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB