Events

Recall of Allura Xper Systems with an attached 7th or 8th monitor Multiple System Codes

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-2018-RN-00071-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00071-1
  • 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 been made aware of a mounting issue with the 7th or 8th monitor to the monitor ceiling suspension. the 7th or 8th monitor attached to the monitor ceiling suspension may disengage from the suspension arm and fall down.Only allura xper systems with an attached 7th or 8th monitor on the monitor ceiling suspension are affected.When a 7th or 8th monitor disengages from the suspension arm it could pose a risk for the patient, user, bystander or service engineer.
  • Action
    Philips will be in contact with all potentially affected users and arrange for the set screws to be secured.

Device

Allura Xper Systems with an attached 7th or 8th monitor Multiple System Codes
  • Model / Serial
    Allura Xper Systems with an attached 7th or 8th monitor Multiple System CodesARTG Number: 225815 (Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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