Events

Recall of Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoroscopic x-ray systems used for diagnostic/interventional procedures in cardiovascular and vascular imaging applications)

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-00588-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00588-1
  • 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 occurrences where the monitor ceiling suspension (mcs) system fell to its lowest position due to an assembly error of the mcs actuator. in one occasion it collided with the table top.
  • Action
    Philips Healthcare is issuing work around instructions as a temporary measure. The affected MCS actuators will be replaced as a permenant fix.

Device

Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoro...
  • Model / Serial
    Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoroscopic x-ray systems used for diagnostic/interventional procedures in cardiovascular and vascular imaging applications)Product codes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025Applies to:Actuator Short Assy: 989600-184-665Actuator Long Assy: 989600-184-654ARTG number: 98560, 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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