Events

Recall of Allura Xper R7.2.x (Fluoroscopic diagnostic 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-2015-RN-00122-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00122-1
  • 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
    In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required. no injuries attributed to the problem are reported.
  • Action
    Philips Healthcare is advising the user to always observe realtime dose information and cumulative fluoro time provided by the system. The fault condition is reset when a new patient case is started or when the system is restarted. Philips Healthcare service engineers will install software release R7.2.8 which addresses the buzzer issue. This action has been closed-out on 3/8/2016.

Device

Allura Xper R7.2.x (Fluoroscopic diagnostic x-ray system)
  • Model / Serial
    Allura Xper R7.2.x (Fluoroscopic diagnostic x-ray system)Product codes: 722003, 722005, 722006, 722008, 722014, 722015 with system software release 7.2.xARTG Number:175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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