22 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·May 28, 2010
HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode.
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·May 28, 2010
HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge.
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·May 28, 2010
HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode.
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·May 28, 2010
HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·April 30, 2010
Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5068A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·April 30, 2010
Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·April 30, 2010
HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CHL·June 19, 2017
HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in accordance with the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC). The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
FDA Recall
Terminated
·Philips North America LLC·Product code MKJ·September 10, 2019
HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC). The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code MKJ·July 26, 2012
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code MKJ·July 26, 2012
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
FDA Recall
Terminated
·Philips North America LLC·Product code MKJ·September 10, 2019
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 Recall
Terminated
·Philips Medical Systems North America Inc.·Product code MKJ·February 6, 2014
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