Events

Recall of REDUNDANT APPLICATION AVAILABILITY

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
    43587
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-12
  • 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
    Ct transcatheter aortic valve implantation (ct tavi) planning applicationsupplied as an option to intellispace portal software version 6 may display incorrect measurements of cardiac and aortic anatomy. clinicians use this information to plan tavi procedures and to select and size the transcatheter heart valve (thv) to be used in the procedures.Reliance on incorrect information could contribute to an unsuccessful thv implantation procedure.

Device

REDUNDANT APPLICATION AVAILABILITY
  • Model / Serial
    Model Catalog: 4598 003 56951 (Lot serial: 550012)
  • Product Description
    CT TAVI Planning Application in Intellispace Portal V.6
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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