Events

Recall of HARMONIC SYSTEM - AIRLESS HANDPIECES

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
    88495
  • Event Risk Class
    III
  • Event Initiated Date
    2012-04-02
  • 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
    The issue is a result of a supplier component change to a chip in the harmonic hand pieces (hp054 & hpblue) that communicates with the generator 300 (gen04). the issue occurs after successful set up and initial use of affected lots of harmonic hand pieces with the generator 300. the procedure is interrupted when the generator 300 goes into stand-by mode after one minute of cumulative activation time (approximately 10 activations). once the generator 300 goes into stand-by mode the device cannot be activated to complete the procedure without fully re-setting the system.

Device

HARMONIC SYSTEM - AIRLESS HANDPIECES

Manufacturer

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