Events

Recall of Multiple Allura systems(Fluoroscopic x-ray systems)

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-00604-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00604-1
  • 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
    Customer reported an issue with a failing monitor ceiling suspension (mcs) actuator of an allura xper system. the actuator assembly had become detached and the monitor carriage with a flexvision monitor dropped to its lowest position. the monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use, and away from the patient when not in use (park position).When the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room. there is also the possibility that the monitor ceiling suspension collides with other equipment in close proximity of the mcs.
  • Action
    Philips will check if the actuator serial number is on the affected product list. If the actuator is on the affected product list the immediate containment action is to secure the MCS with straps to prevent the monitors to fall down in case the actuator fails. Actuators on the affected products will be replaced by Philips. In order to avoid any risk for patients, users or bystanders Philips recommend the following until the containment action FCO has been implemented: - Do not position or move the Monitor Ceiling Suspension above the patient. - Do not allow staff to stand under or close to the Monitor Ceiling Suspension. Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 15/08/2016.

Device

Multiple Allura systems(Fluoroscopic x-ray systems)
  • Model / Serial
    Multiple Allura systems(Fluoroscopic x-ray systems)Systems affected:Allura Xper FD10Allura Xper FD10/10Allura Xper FD20Allura Xper FD20/10Allura Xper FD10 OR TableAllura Xper FD20 OR TableAllura Xper FD10/10 OR TableAllura Xper FD20 Biplane OR TableProduct Codes - 722010, 722011, 722012, 722013, 722022, 722023, 722024 &722025.Applies to - Actuator Short Assy: THC8AWDS-121 989600-184-665 & Actuator Long Assy: THC8AWDS-122 989600-184-654ARTG Number: 175708
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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