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
    108474
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-25
  • 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 had received a call with respect to an issue with a failing monitor ceiling suspension (mcs) actuator of an allura xper system. the actuator assembly had become detached and the monitor carriage with a flexvision monitor dropped to its lowest position. the monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use and away from the patient when not in use. (park position).

Device

ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: ALLURA XPER FD20/10 (Lot serial: >10 contact mfg.); Model Catalog: ALLURA XPER FD10/10 (Lot serial: >10 contact mfg.); Model Catalog: ALLURA XPER FD20 (Lot serial: >10 contact mfg.); Model Catalog: ALLURA XPER FD20/20 (Lot serial: > 10 contact mfg.); Model Catalog: ALLURA XPER FD10 (Lot serial: >10 contact mfg.)
  • Product Description
    Allura XPER FD20/10
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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