Events

Recall of Allura Xper FD(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)

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-00831-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00831-1
  • 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 discovered through customer complaints and internal testing an intermittent electronic product defect. in certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required in 21cfr1020.32 (h)(2)(ii) and iec 60601-2-54, clause 203.6.2.1.C.
  • Action
    A mandatory Field Change Order (FCO) with reference FCO72200285 is being released that requires Philips field service engineers to install Software release R8.2.16 which addresses the buzzer issue. This action has been closed-out on 12/05/2017.

Device

Allura Xper FD(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Model / Serial
    Allura Xper FD(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)AFFECTED PRODUCTSAllura Xper FD with product codes: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059.ARTG: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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