Events

Recall of Allura Xper Systems(Fluoroscopic angiographic digital 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-2014-RN-01104-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01104-1
  • 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
    If a footswitch is frequently used on an anti-fatigue mat, on a not flat surface or in the pedestal, the footswitch pedals may get bent. this might cause an intermittent or continuous inability of making live fluoroscopy images or exposures. in case the fluoroscopy pedal is bent and live fluoroscopy is not available, the exposure pedal of the footswitch or the hand switch may be used to generate a live image in order to finish a procedure, this will lead to a higher dose but it outweighs the potential safety risk.
  • Action
    Philips Healthcare is advising the customers to check the footswitch for bent pedals before the start of a procedure and if bent pedals are found the procedure should not continue and local Service should be contacted. Philips Healthcare is performing the hardware update of the Footswitch in order to prevent bent pedals and therefore prevents an intermittent or continuous inability of making live fluoroscopy images or exposures. This action has been closed-out on 11/08/2016.

Device

Allura Xper Systems(Fluoroscopic angiographic digital x-ray system)

Manufacturer

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