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
    18683
  • Event Initiated Date
    2015-06-18
  • 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
    When certain values are used as the highest colour table level, the corresponding isodose line for display of dose and dose difference is not displayed., when certain values are used as the highest colour table level, and when using the discrete level option, values at or above the highest colour table level will be coloured as the second highest level for dose, dose difference or pet images.
  • Action
    Software to be upgraded

Device

RaySearch RayStation Radiation therapy treatment planning system

Manufacturer

RaySearch Laboratories AB