Events

Recall of Allura Xper FD20 R8.2

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-00898-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00898-1
  • 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 identified that the protecting earth (pe) cable between a motion controller and the pe star point was not installed on the affected product.The lack of this aforementioned protective earth cable makes the system not compliant with the iec60601-1 standard for protective earthing, however there is no risk for patients / operators / users since the frame is connected to protective earth (pe) and the unit involved is shielded with a cover.The relevant parts are in the technical (equipment) room and therefore not accessible for patients. to date, philips is not aware of any injuries that may have occurred as result of this situation.
  • Action
    Philips is requesting customers: 1. Read the supplied notice; 2. Place the notice with the documentation of the system until this correction has been implemented; and 3. Complete the supplied response form and return it to Philips via fax/email within 3 business days of receiving the customer letter.

Device

Allura Xper FD20 R8.2

Manufacturer

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