Events

Recall of RaySearch RayStation - Radiation 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
    15008
  • Event Initiated Date
    2013-07-17
  • 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
    As issue has been identified in the raystaion 3.0 and 3.5 dose volume statistics calculation. under certain conditions resampling of regions of interest (roi) geometries to the dose grid representations is not correctly calculated and an additional voxel layer is added incorrectly on the superior side of each roi., the problem is pronounced for very small rois, leading to a possible over estimation of the dose maximum or a possible under estimation of the dose minimum, thus always erring on the safe side. worst-case scenario is delivering less dose than optimal to target organs.
  • Action
    Manufacturer to issue advice regarding use

Device

RaySearch RayStation - Radiation therapy treatment planning system

Manufacturer

RaySearch Laboratories AB