Events

Recall of RaySearch RayStation 5 (Radiation therapy treatment planning system)

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-2016-RN-01364-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01364-1
  • 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
    An issue has been identified with the display of dose computed on images other than the planning ct (auxiliary ct) when using multiple patient cases in raystation 5. if a ct image set with the same frame of reference (for) as the displayed auxiliary ct set exists in another case, the dose display may be incorrect. the issue occurs when a plan in one case is used to compute dose on another image set, and when that image set has the same for as an image set in another case. this happens when using the function “compute dose on other data set” in the plan evaluation module or when computing fraction doses in the dose tracking module. the visual display of dose in the patient views can be incorrect and can be shifted and/or rotated. the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. the dose value normally displayed in the upper left corner when pointing in the 2d view may be incorrect or missing.
  • Action
    The issue will be resolved in the next version of RayStation, scheduled for market release December 2016. Until a corrected version has been installed, all affected users must maintain awareness of the issues. Specifically, be aware that when a patient has multiple cases, the following may be incorrect if there are image sets that share the same Frame of Reference residing in different cases: - Display of evaluation dose computed on another CT image set - Dose tracking fraction dose and deformed dose. In these cases, the display of the dose values in the 2D view, including the dose value shown when pointing in the view, maximum dose position, dynamic isodose lines and dose grid display may be incorrect.

Device

RaySearch RayStation 5 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia