Events

Recall of STOCKERT EP SHUTTLE SYSTEM - COMPLETE SYSTEM

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
    44870
  • Event Risk Class
    III
  • Event Initiated Date
    2011-07-27
  • 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 inc. (a johnson & johnson company) recently became aware that the stockert ep shuttle system release notes describing software anomalies for versions 1.035 and 1.037 were not previously communicated or provided to all customers. the field notification is being issued to all customers to provide them with release notes.

Device

STOCKERT EP SHUTTLE SYSTEM - COMPLETE SYSTEM

Manufacturer

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