Events

Recall of ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management)

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-2012-RN-01084-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01084-1
  • 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 anomaly has been identified with the aria oncology information system version 11 where monitor units of one fraction may be incorrect, when partial treatment is being continued. the issue happens when a treatment is interrupted mid-field (for example, by a power loss) and the delivered monitor units for the partially treated field are entered manually in the treatment record. when the partial treatment is resumed, the system will not use the full remaining planned monitor units for the affected field, thus leaving the fraction under dosed.
  • Action
    Varian is recommending users to implement work around instructions until a software fix is developed and implemented.

Device

ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the ...
  • Model / Serial
    ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management)Product code: HITAffected serial numbers: HIT0339M and HIT0339R1ARTG Number: 132638
  • Product Classification
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd