Events

Recall of SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

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
    26990
  • Event Risk Class
    II
  • Event Initiated Date
    2015-09-28
  • 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
    Biosense webster is initiating a field safety notice for the cartosound module of the carto 3 ep navigation system [see second recall record] when used with the soundstar eco 8f diagnostic ultrasound catheter following one complaint of image disappearance from the cardiac ultrasound system when the carto 3 ep navigation system needed restarting. this occurred while the patient was experiencing pericardial effusion. this notice is not a product removal and it is not necessary for users to return any catheters.

Device

SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.