Events

Recall of Allura Xper R8.2 and UNIQ R1.0 X-Ray Systems (diagnostic, fluoroscopic 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-2016-RN-00881-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-07-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00881-1
  • 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 identified through trend analysis an increase in the failure rate of certain low-voltage dc power supplies (“dcps”) used in the affected products. each system contains multiple dcps, some of which may be subject to an increased probability of failure. failure of a dcps may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the dcps is powering. the likelihood of a system failure to occur is remote.The loss of key imaging functionality or mechanical movement during a diagnostic or therapeutic procedure may interrupt or require the abandonment of the procedure. in rare instances, unavailability of live imaging might lead to a possible injury to the patient when the system fails during a critical phase of the procedure.
  • Action
    Philips will replace the affected DCPS. Philips Healthcare service representative will contact customers with affected devices to arrange for the service. In the interim, the users are recommended to follow their pre-established procedures for managing potential patient safety in the event that the system shuts down.

Device

Allura Xper R8.2 and UNIQ R1.0 X-Ray Systems (diagnostic, fluoroscopic x-ray system)
  • Model / Serial
    Allura Xper R8.2 and UNIQ R1.0 X-Ray Systems (diagnostic, fluoroscopic x-ray system)All Allura Xper R8.2 systems are affected and the following have been identified in Australia:Allura Xper FD10, 722026Allura Xper FD10/10, 722027Allura Xper FD20, 722028Allura Xper FD20 OR Table, 722035Allura Xper FD20/20 biplane OR Table, 722039Allura Xper FD20/15, 722058ARTG Number: 175708
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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