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
    18523
  • Event Initiated Date
    2015-05-14
  • 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 vmat control points are distributed with a wider gantry angle spacing than 4 degrees, the dose calculation will not be accurate. such plans will never be generated by raystation and imported plans with this wide gantry angle spacing will normally not be possible to use for dose calculation in raystation. however, if the imported plan is assigned to a vmat enabled machine model with minimum dose rate = 0.00 mu/min and minimum gantry speed = 0.0 degrees/s, it is possible to calculate dose., , depending on the individual plan, local dose inaccuracy in some regions close to the patient surface may range from under a percent to several percent of dose max. the deviation increases with the gantry angle spacing and with the number of affected control points. the problem will mainly occur in the region furthest away from the isocenter.
  • Action
    Software to be upgraded

Device

RaySearch RayStation Radiation therapy treatment planning system

Manufacturer

RaySearch Laboratories AB