Events

Recall of RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation treatment planning and analysis software) Date Manufactured: 15/02/2013

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-2013-RN-00734-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00734-1
  • 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
    Under certain conditions resampling of regions of interest (roi) geometries to the dose grid representation is not correctly calculated, and an additional voxel layer is added incorrectly on the superior side of each roi. the problem is more pronounced for very small roi's, leading to over-estimation of dose maximum and under-estimation of the minimum dose.The above problem also affects dose calculated with material overrides, however this should cause no noticeable impact.
  • Action
    Emergo are providing work around instructions for users to follow. The issue will be corrected in RayStation software version 4.0 which is due for release in July 2013.

Device

RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation trea...
  • Model / Serial
    RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation treatment planning and analysis software)Date Manufactured: 15/02/2013ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia