Events

Recall of Philips Allura Xper 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-2017-RN-00432-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00432-1
  • 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
    Through customer complaints, philips has discovered problem with the detector cooling system for a limited number of allura xper and allura cv20. due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. if this occurs the liquid may drip onto electrical components in the r-cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odour, smoke or fire. to date, philips is not aware of any injuries that may have occurred as a result of this problem.
  • Action
    Philips is advising users that if a burning odour, smoke or fire is detected coming from the technical room, the main switch should be turned off and system taken out of service immediately. In the event of a hazardous situation, users are requested to adhere to their workplace emergency procedures. Once any hazardous situation has been abated, users are advised to inform their local Philips representative. (Please note: Philips will start inspecting affected systems for leaks and repair as required. In addition as from April 2017, Philips will undertake a free installation of an extended drip tray on affected systems to prevent damage from any future leaks).

Device

Philips Allura Xper X-Ray Systems
  • Model / Serial
    Philips Allura Xper X-Ray SystemsAllura Xper and Allura CV20 Releases 3 to 8.1 with an installed Laird chillerAllura Xper Release 8.2: only configurations FD10, FD10/10, FD20/10, FD20/20 have a Laird chillerMultiple Product Names and CodesARTG Number: 225815
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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