Events

Recall of RayStation and RayPlan

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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
    RC-2018-RN-00128-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00128-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has identified that when more than one beam is defined on the same isocenter, the center beam in field (cbf) affects all beams in a way that the user may not expect.After using cbf, the resulting fields are clearly displayed in raystation/rayplan for review and approval. however, one mistreatment incident using the cbf functionality has been reported where the user failed to review the resulting beam apertures before treatment delivery.
  • Action
    Emergo will be contacting users to update to the next version of RayStation/RayPlan. In the interim, users are advised: · Be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended. · Do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam.

Device

RayStation and RayPlan
  • Model / Serial
    RayStation and RayPlanModel Numbers: RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) andRayStation 7 (RayPlan 7)Serial Numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or7.0.0.19ARTG Number: 195288(Emergo Asia Pacific Emergo Australia - Radiation therapy treatment planning system)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia