Events

Recall of ALLURA XPER FD20/15

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
    64935
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-16
  • 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 trend analysis an increase in the failure rate of certain anode drive units (adus) used in these products. early life failure of the adus only occurs when the hospital mains provide 480v to the system. when the adu fails the x-ray performance of the system is reduced to emergency fluoroscopy. exposure will not be possible and image quality is reduced.

Device

ALLURA XPER FD20/15
  • Model / Serial
    Model Catalog: 722058 (Lot serial: 110 / 65331325); Model Catalog: 722035 (Lot serial: 111 / 67475814); Model Catalog: 722035 (Lot serial: 128 / 68199187); Model Catalog: 722038 (Lot serial: 102 / 65331332); Model Catalog: 722028 (Lot serial: 1261 / 70828850); Model Catalog: 722028 (Lot serial: 1056 / 69430666); Model Catalog: 722028 (Lot serial: 1039 / 69397862); Model Catalog: 722028 (Lot serial: 942 / 68733944); Model Catalog: 722028 (Lot serial: 663 / 66650325); Model Catalog: 722028 (Lot serial: 878 / 68280389); Model Catalog: 722028 (Lot serial: 763 / 67493645); Model Catalog: 722028 (Lot serial: 758 / 67476532); Model Catalog: 722028 (Lot serial: 742 / 67341881); Model Catalog: 722028 (Lot serial: 905 / 68002624); Model Catalog: 722026 (Lot serial: 759 / 69723007); Model Catalog: 722026 (Lot serial: 866 / 67402179); Model Catalog: 722026 (Lot serial: 830 / 70417112); Model Catalog: 722026 (Lot serial: 271 / 64615994); Model Catalog: 722026 (Lot serial: 707 / 69150243); Model Catalog: 722026 (Lot seria
  • Product Description
    ALLURA XPER FD20/15;ALLURA XPER FD20 OR TABLE (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD10 (PRODUCT OF ALLURACLARITY FAMILY)
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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