Events

Recall of Raystation RaySearch therapy 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
    16240
  • 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 manufacturer advises there is an issue with the dose calculation in specific versions of the raystation software. the error appears in some situations for bolus/external/fixation/support structures that are outside the image stack but covered by the dose grid. when converted to dose grid structures they are cut off at the image stack boundaries (first and last slice) in the inferior-superior direction. for a bolus/external/fixation/support structure this means that the part outside the image stack does not contribute to the density distribution and the dose calculation will be affected. only structures before the first slice or after the last slice are affected, not structures outside the image stack in the anterior/posterior/left/right direction.
  • Action
    Software to be upgraded

Device

Raystation RaySearch therapy treatment planning system
  • Model / Serial
    Model: , Affected: , Software version: Versions: 2.0, 2.5, 3.0, 3.5, 4.0
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB