Events

Recall of Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system) Software versions prior to 8.1.0.3 are affected

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-2013-RN-00113-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00113-1
  • 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 using the targano wheel or speed slider to increase the image speed during the replay of a vascular biplane run, with different image sized on disk in the frontal and lateral channel (1024x1024 or 2048x2048), an image processing error will occur resulting in a system hang up.
  • Action
    Siemens is advising the customers that until the corrective action has been implemented, the Targano wheel or speed slider should not be used to effect the image speed during replay of a vascular bi-plane run. Philips is providing a software upgrade (v 8.1.0.3) to correct the issue.

Device

Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system)...
  • Model / Serial
    Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system) Software versions prior to 8.1.0.3 are affectedProduct Codes: 722013 & 722025 ARTG number: 175708
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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