Events

Recall of RaySearch 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
    20610
  • Event Initiated Date
    2016-09-06
  • 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
    Two issues have been identified with the dose calculation when using a region of interest (roi) of type fixation or support with material override within the patient outline in raystation models., 1. 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., 2. 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.
  • Action
    Instructions for use to be updated

Device

RaySearch Radiation Therapy Treatment Planning System

Manufacturer

RaySearch Laboratories AB