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Sources: EU EUDAMED, US FDA
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Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
FDA Recall
Terminated
·Defibtech LLC·Product code MKJ·May 21, 2010
ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
FDA Recall
Terminated
·Defibtech LLC·Product code MKJ·May 21, 2010
Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·October 14, 2024
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·October 14, 2024
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·October 14, 2024
Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA.)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·October 14, 2024
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·February 17, 2007
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·February 17, 2007
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
Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED.
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·April 1, 2011
DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·April 27, 2020
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·March 18, 2025
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·March 18, 2025
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·February 14, 2023
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·April 27, 2020
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·March 18, 2025
RMU-2000 Automated Chest Compression Device
FDA Recall
Open, Classified
·Defibtech, LLC·Product code DRM·July 12, 2024
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1(German/English dual language), DCF-E2310E3/1(German/French dual language), DCF-E2310F3/1 (French/English dual language), DCF-E2310G3/1(French/German dual language), DCF-E2310IT (Italian language)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·March 18, 2025
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287, 00815098020317 Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·April 27, 2020
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·March 18, 2025