Defibtech, LLC
Medical device manufacturer in Guilford, CT.
9510(k) clearances
1PMA approvals
20recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K211289 | RMU-2000 Automated Chest Compression SystemDRM · Traditional | 11/09/2021SE |
| K141809 | RMU-1000 Automated Chest Compression SystemDRM · Traditional | 10/27/2014SE |
| K131525 | Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | 04/24/2014SE |
| K113787 | DDU-120 Fully Automatic External Defibrillator and AccessoriesMKJ · Traditional | 01/04/2013SE |
| K121853 | DDU-2400/2450 Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | 12/13/2012SE |
| K081259 | DDU-2300 Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | 06/15/2009SE |
| K033896 | Defibtech AED with Attenuated Defibrillation/Monitoring Pads, Models DDU-100 with DDP-200PMKJ · Traditional | 06/16/2004SE |
| K033144 | Defibtech Electrode Adapter, Model DAC-300 SeriesMKJ · Traditional | 11/13/2003SE |
| K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)…MKJ · Traditional | 06/19/2002ST |
PMA approvals
- P160032 Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- · 02/01/2018 · 17 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1694-2025 Class II | Automated External Defibrillators, Model DDU-2200, IItem numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | 03/18/2025Open, Classified |
| Z-1693-2025 Class II | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | 03/18/2025Open, Classified |
| Z-1692-2025 Class II | Automated External Defibrillators, Model DDU-2300. Item numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | 03/18/2025Open, Classified |
| Z-1691-2025 Class II | Automated External Defibrillators, Model DDU-2200, IItem numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | 03/18/2025Open, Classified |
| Z-1690-2025 Class II | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | 03/18/2025Open, Classified |
| Z-0505-2025 Class II | Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View…Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized… | 10/14/2024Open, Classified |
| Z-0504-2025 Class II | Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View…Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized… | 10/14/2024Open, Classified |
| Z-0503-2025 Class II | Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline…Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized… | 10/14/2024Open, Classified |
| Z-0502-2025 Class II | Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and…Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled… | 10/14/2024Open, Classified |
| Z-2543-2024 Class I | RMU-2000 Automated Chest Compression DeviceProblem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy… | 07/12/2024Open, Classified |
| Z-1312-2023 Class II | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of…A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability… | 02/14/2023Open, Classified |
| Z-2394-2020 Class II | DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR…A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an… | 04/27/2020Terminated |
| Z-2393-2020 Class II | DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External…A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an… | 04/27/2020Terminated |
| Z-2392-2020 Class II | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN…A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an… | 04/27/2020Terminated |
| Z-2064-2011 | Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version…Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the… | 04/01/2011Terminated |
| Z-0077-2011 | DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external…Data cards may include an incorrect format which may cause the AED to not function correctly. | 08/27/2010Terminated |
| Z-1782-2010 | ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack.…The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and… | 05/21/2010Terminated |
| Z-1781-2010 | Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery…The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and… | 05/21/2010Terminated |
| Z-0581-2007 | Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand…Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery… | 02/17/2007Terminated |
| Z-0580-2007 | Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand…Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery… | 02/17/2007Terminated |