Events

Recall of Device Recall Powerheart AED, G3, 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
    59303
  • Event Risk Class
    Class 2
  • Event Number
    Z-3265-2011
  • Event Initiated Date
    2011-06-30
  • Event Date Posted
    2011-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102214
  • 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
    Cardiac science corporation (csc) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the g3 installed base over the last 6 years. these self test errors cause the device to enter into a service required state. csc remind owners/operators of the powerheart aed devices to verify the "rescue readiness" of their equipment and follow maintenance pro.
  • Action
    Cardiac Science began mailing out the recall notification letter on August 1, 2011, to all their US consignees via USPS first class mail. Cardiac Science's distribution partners will receive a notification letter and be provided with a template letter to send to their customers directly. CSC remind owners/operators of the Powerheart AED devices to check the status of of the AED every day to ensure it is Rescue Ready, and perform the regularly schedule maintenance as outlined in the Powerheart AED "Operator and Service Manual" provided with every AED. Customers can call Cardiac Science at 800-426-0337 or e-mail at aed205@cardiacscience.com.

Device

Device Recall Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED
  • Model / Serial
    Serial numbers: 022805, 031605, 303024, 322627, 322644, 328877, 900034, 900055, 900061, 900110, and 972196. Serial numbers Ranges:  from 900134 through 903240;  from 329024 through 394573; from 400001 through 4049272;  from 4100002 through 4370573;  from 92532-0000501 through 92532-0001310; and from 92533-0000000 through 92533-0001340.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) This action applies only to domestic
  • Product Description
    Powerheart Automated External Defibrillator (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. || Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440. || Brand names: Powerheart AED, G3, CardioVive AED, GE Responder || AED, Nihon Kohden CardioLife AED.
  • 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