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Sources: EU EUDAMED, US FDA
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HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MKJ·March 30, 2009
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
Biphasic LIFEPAK 12 defibrillator / monitor.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MKJ·March 31, 2009
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MKJ·January 28, 2013
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
FDA Recall
Terminated
·ZOLL Medical Corporation·Product code MKJ·March 5, 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
LIFEPAK EXPRESS defibrillator
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code MKJ·January 31, 2006
HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality of CPR. The Q-CPR option offers real time measurement and corrective feedback on the rate, depth and complete release of compressions, ventilations rate and lack of CPR activity in accordance with current CPR guidelines. The Q-CPR option is contraindicated as follows: *The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg). *The Q-CPR option is not for use when CPR is contraindicated.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MKJ·May 6, 2010
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
FDA Recall
Terminated
·Heartsine Technologies, Limited
203 Airport Road West
Belfast United Kingdom·Product code MKJ·June 12, 2014
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
FDA Recall
Terminated
·Bio-Detek, Inc.·Product code MKJ·September 16, 2014
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
FDA Recall
Terminated
·Bio-Detek, Inc.·Product code MKJ·September 16, 2014
Cardiac Science Powerheart Automated External Defibrillator G3 9300A
FDA Recall
Terminated
·Cardiac Science Corporation·Product code MKJ·October 13, 2008
ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
FDA Recall
Terminated
·ZOLL Medical Corporation, World Wide Headquarters·Product code MKJ·March 24, 2010
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+ 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, 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
DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·August 27, 2010
LIFEPAK EXPRESS defibrillator
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code MKJ·October 5, 2006
LIFEPAK 500 automated external defibrillator
FDA Recall
Terminated
·Medtronic Physio Control Corp·Product code MKJ·April 2, 2004