Events

Recall of ALLURA XPER FD10

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS 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
    38431
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Philips has discovered through customer feedback and internal testing the following issues: 1. a failure with the image disk may cause the entire image processing chain to be blocked due to a sw design error. this causes image data to be lost and eventually loss of live imaging functionality. 2. a filament error that may occur during the execution of an xperct. when the filament error occurs the run is aborted. after abort new x-ray runs can be started immediately without system restart.

Device

ALLURA XPER FD10
  • Model / Serial
    Model Catalog: ALLURA XPER FD10 (Lot serial: ALL); Model Catalog: 722038 (Lot serial: ALL); Model Catalog: 722028 (Lot serial: ALL)
  • Product Description
    ALLURA XPER FD10;ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY)
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC