Events

Recall of RaySearch RayStation 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
    20245
  • Event Initiated Date
    2016-06-07
  • 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
    An issue has been found with the treatment plan report in raystation 5. for a treatment plan with multiple beam sets, the table for roi plan dose statistics in the report may show the statistics for a beam set dose. the error can only be triggered when using a report template where statistics for a beam set dose are included as the last dose statistics prior to the plan dose statistics. for such a report template, all reports for multiple beam set plans would always be affected., the user must be aware of information to avoid incorrect assessment of treatment plan dose levels. i.E inspect all report templates that are intended to be used for plans with multiple beam sets. make sure that "poi dose statistics (plan)" is included immediately before "roi dose statistics [plan dose]" in the report content area., this issue will be resolved in the next version of raystation, scheduled for market release nov 2016.
  • Action
    Manufacturer to issue advice regarding use

Device

RaySearch RayStation Treatment Planning System
  • Model / Serial
    Model: , Affected: , Software version: 5.0.0.37, 5.0.1.11 and 5.0.2.35
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB