Events

Recall of Allura Xper with FlexVision large screen monitor

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-2018-RN-00830-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00830-1
  • 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 has received reports of instances where after a continuous operation of more than one and a half days, the image on the flexvision large screen monitor froze for about 15 seconds. thereafter, the system restored itself and was fully operational again.This is only applicable to allura systems with a flexvision large screen monitor. all other monitors to the system are not affected.To date, philips is not aware of any injuries that may have occurred due to this issue.
  • Action
    Philips is advising this issue will be resolved in a software upgrade, expected to be available by the second half 2018. Users will be contacted by Philips when the software is available for installation. In the interim, users are advised to restart the system at least once per day to prevent occurrence of this issue.

Device

Allura Xper with FlexVision large screen monitor
  • Model / Serial
    Allura Xper with FlexVision large screen monitorSystem names: Allura 8.1.25.0, Allura 8.1.25.1, Allura 8.1.25.5, Allura 8.2.25.0, Allura 8.2.25.5 and Allura 8.2.27 ARTG Number: 225815(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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