Events

Recall of Device Recall Powerheart AED, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Science 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
    Recall
  • Event ID
    60992
  • Event Risk Class
    Class 1
  • Event Number
    Z-1057-2012
  • Event Initiated Date
    2012-01-13
  • Event Date Posted
    2012-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107002
  • 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
    The affected automated external defibrillators (aeds) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. if the component were to fail during a rescue attempt, the aed may not deliver defibrillation therapy.
  • Action
    Cardiac Science sent an "URGENT-Voluntary Medical Device Recall" letter dated January 13, 2012 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to immediately return the device to the manufacturing location for repair. The affected devices will receive a hardware correction, and the same serial number device returned to the consignee in most cases. Customers in the US can call 1-888-402-2484 and customers outside the US can call 1-425-402-2482 or email at aed210@cardiacscience.com to arrange delivery of the shipping materials. Customers can also visit www.cardiacscience.com/aed210 for more information about AEDs affected by this recall.

Device

Device Recall Powerheart AED, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and Puerto Rico; and to the following countries: Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Malaysia, Maldives, Malta, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saint Lucia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, Ukraine, and United Kingdom.
  • Product Description
    Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Responder 2019198, 2023440 AEDs. || The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. The device is intended to be used by personnel who have been trained it is operation. The user should be qualified by training in basic life support or other physician-authorized medical response.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • Manufacturer Address
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Manufacturer Parent Company (2017)
    Cardiac Science Corporation
  • Source
    USFDA