Events

Recall of Device Recall Power Heart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Science, 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
    29026
  • Event Risk Class
    Class 2
  • Event Number
    Z-0991-04
  • Event Initiated Date
    2004-05-04
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33181
  • 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
    Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.
  • Action
    A recall letter, dated May 10, 2004, stated that a replacement battery is enclosed with the letter, and instructed consignees to install the new battery in their defibrilllator and return the old battery.

Device

Device Recall Power Heart
  • Model / Serial
    The recalled Model 9143 Batteries have the following lot numbers: 7851, 7852, and 7856.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The batteries were distributed with the defibrillators nationwide in the United States and to foreign consignees in Europe, Asia, Latin America, the Middle East and Africa.
  • Product Description
    FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9143
  • Manufacturer
    Cardiac Science, Inc.

Manufacturer

Cardiac Science, Inc.
  • Manufacturer Address
    Cardiac Science, Inc., 1900 Main Street, Suite 700, Irvine CA 92614
  • Source
    USFDA