Recall of Device Recall Zoll AED Plus Defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Medical Corporation.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    Defibrillator may fail to function due to false detection of safety fault condition.
  • Action
    Zoll Medical notified Direct accounts by letter issued Overnight Certified Mail on 12/17/02 to Domestic Accounts and 12/18/02 to International accounts.


  • Model / Serial
    Serial Numbers: X02F000812 through X02K007486
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide to : Hospitals, EMT, Police and Fire Rescue
  • Product Description
    Zoll AED Plus Defibrillator (Automatic External Defibrillator)
  • Manufacturer


  • Manufacturer Address
    Zoll Medical Corporation, 32 Second Avenue, Burlington MA 01803
  • Source