BEUDAMED
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    Philips HeartStart FRx AED.

    FDA Recall
    Terminated ·Philips Electronics North America Corp.·Product code MKJ·March 14, 2018

    Philips HeartStart (HS1) Onsite/Home AED

    FDA Recall
    Terminated ·Philips Electronics North America Corp.·Product code MKJ·March 14, 2018

    Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.

    FDA Recall
    Terminated ·Philips Electronics North America Corp.·Product code MKJ·October 10, 2018

    Philips HeartStart FRx AED.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corp.·May 30, 2018

    Philips HeartStart (HS1) Onsite/Home AED

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corp.·May 30, 2018

    Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corp.·October 24, 2018