Events

Recall of Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic x-ray system)

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-2016-RN-00274-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00274-1
  • 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
    Philips healthcare has identified through customer complaints and internal testing that uncontrolled geometry movements can occur when the system is not switched on/off regularly. due to the nature of the problem, the user will perceive a gradually increased sluggishness. upon activation of the iu controls an uncontrolled geometry movement can occur. the uncontrolled movements are immediately stopped upon release of the iu controls. all safety measures such as current sensing, 3d model and bodyguard remain intact avoiding serious harm to patient and bystander. a system reboot will restore normal system operation.
  • Action
    Philips is advising users to regularly restart the system as per the Instructions for Use (IFU) once a day to avoid uncontrolled movements. A software update will be provided as a permanent fix. This action has been closed-out on 26/05/2017.

Device

Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic x-ray system)
  • Model / Serial
    Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic x-ray system)ARTG Number: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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