Events

Recall of RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with radiation therapy systems)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Varian Medical Systems Australasia Pty Ltd.

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-00371-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00371-1
  • 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
    While operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. the error may be reproduced if the rpm system is induced to frequently lose and reacquire tracking of the 6-dot marker block during a calibration sequence, a reference session or a single session after tracking has begun.
  • Action
    Varian is providing temporary work around instructions and is implementing a software update to permanently correct the problem.

Device

RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring syst...
  • Model / Serial
    RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with radiation therapy systems) Product code: H50Multiple serial numbers affectedARTG Number: 117951
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd