BEUDAMED
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    GEMINI GXL 16 POWER

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code KPS·March 16, 2010

    GYROSCAN ACS-NT

    FDA Adverse Event
    Other ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code LNH·July 20, 2000

    NI

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code ITY·April 7, 2000

    PHILIPS

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code JAA·May 27, 1999

    PICKER CLINIX PLUS

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code JAA·May 20, 2011

    PHILIPS HEARTSTART MRX DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code MKJ·February 4, 2020

    PHILIPS HEARTSTART XL DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code MKJ·March 27, 2020

    PHILIPS INTELLIVUE MP50 PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code MHX·January 24, 2020

    PHILIPS HEARTSTART XL DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code MKJ·March 18, 2020

    PHILIPS M3002A X2 MONITOR/MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code MHX·August 19, 2019

    PHILIPS INTELLIVUE MP5 PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.·Product code MHX·August 19, 2019

    PHILIPS 1.5T INTERA

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA INC.·Product code LNH·September 23, 2010

    Philips Medical Systems Nederland B.V.

    Authorized representative
    🇳🇱 Netherlands·21 Manufacturers·1029 Devices

    Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Inc.·March 26, 2014

    Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Inc.·March 26, 2014

    EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Inc.·November 27, 2013

    Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. 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 defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) 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.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Inc.·March 26, 2014

    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Inc.·March 26, 2014

    Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. 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 defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) 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.

    FDA Recall
    Terminated ·Philips Medical Systems North America Inc.·Product code MKJ·February 6, 2014

    Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.

    FDA Recall
    Terminated ·Philips Medical Systems North America Inc.·Product code IYN·February 28, 2014