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    Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated External Defibrillator

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·October 13, 2008

    Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·June 29, 2011

    Powerheart G5 Automatic AED

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·June 4, 2019

    GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·October 13, 2008

    9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.

    FDA Enforcement
    Class II ·Terminated·Cardiac Science Corporation·March 2, 2016

    Powerheart¿ G5 Automatic AED

    FDA Enforcement
    Class II ·Terminated·Cardiac Science Corporation·July 10, 2019

    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.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·June 30, 2011

    Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Cardiac Science Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Cardiac Science Powerheart Automated External Defibrillator G3 9300A

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·October 13, 2008

    Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code IOL·March 30, 2009

    Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: GE. Product name: Responder. Device Operation: Semi-automatic w/manual override. Color: GE Gold. Voice Prompt Level: Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: Yes.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·February 3, 2010

    Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic w/manual override. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: Yes.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·February 3, 2010

    Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·January 23, 2008

    NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Burdick. Product name: Cardiovive. Device Operation: Semi-automatic. Color: Blue. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·February 3, 2010

    GE Responder 2019198 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009