Events

Recall of ALLURA XPER FD20/10 SYSTEM - MAIN UNIT

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
    30176
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-18
  • 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
    There is a performance issue during initializing of application that could lead to the unavailability of the follow c-arc function. as a consequence the function cannot be used but this will not impact patient safety.

Device

ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: ALLURA XPER FD20/10 (Lot serial: ); Model Catalog: ALLURA XPER FD10/10 (Lot serial: N/A FOR ALL); Model Catalog: ALLURA XPER FD20 (Lot serial: ); Model Catalog: ALLURA XPER FD20/20 (Lot serial: ); Model Catalog: ALLURA XPER FD10 (Lot serial: )
  • Product Description
    ALLURA XPER FD20/10 SYSTEM-MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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