Events

Recall of VariSource iX Control Software

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-2015-RN-01010-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01010-1
  • 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 varisource ix control software. in the event a forced logoff occurs while the dummy wire is extended during a treatment session, the partial fraction generated by the system will be incorrect. the control software does not differentiate the re-start dummy sweep from the dummy sweep at the beginning of the treatment session. the control software assumes no treatment has been delivered. the partial fraction generated will be equivalent to the original full fraction. if this partial fraction is treated, this would result in re-treatment of any dwell positions actually delivered prior to the session interrupt and result in a dose greater than intended. the treatment recovery report will incorrectly indicate that no dwell positions have been treated. both the treatment delivery report and the treatment history report do correctly indicate the dwell positions treated.There have been no reports of patient injury due to this issue.
  • Action
    Varian Medical Systems is developing a technical correction for this issue. A Technical Service representative will contact the affected hospital when this correction is available to schedule its installation. In the interim a workaround is provided in the Customer Letter.

Device

VariSource iX Control Software

Manufacturer

Varian Medical Systems Australasia Pty Ltd