Events

Recall of Pinnacle3 Radiation Treatment Planning System, software version 9.0

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2014-RN-00291-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00291-1
  • 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
    When the user changes from one treatment machine to another, the jaw symmetry yes or no option may be set incorrectly to symmetric. when exported via dicom rt, multileaf collimator (mlc) and jaw positions agree with the pinnacle3 plan. however, because the jaw symmetry flag is set to yes, the record and verify (r&v;) system may force the jaws to be symmetric, thereby re-positioning the beam. the resulting beam on the r&v; system does not match the beam in pinnacle3 resulting in an incorrect dose to the target or other structure. if the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.
  • Action
    Philips is providing an update to software version 9.2 to all customers who have software version 9.0 installed. Until the update is applied, customers are advised to manually cick the button to set it to No if they observe the jaw symmetry is set to Yes inappropriately.

Device

Pinnacle3 Radiation Treatment Planning System, software version 9.0

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA