Defibtech, LLC
United StatesFDA applicant, unverified FDA FEI 3003521780
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 2011 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Defibtech, LLC makes
Defibtech, LLC manufactures automated chest compression systems, semi-automatic and fully automatic external defibrillators, and associated accessories such as defibrillation pads, battery packs, and electrode adapters. Their products include standalone AED systems designed for emergency cardiac care, as well as specialized pads for attenuated defibrillation and monitoring. The portfolio also covers mechanical devices to support chest compressions during resuscitation efforts.
Defibtech’s devices are regulated under FDA classifications, with Class II and Class III products subject to 510(k) and PMA pathways, respectively. The company’s products are listed in the FDA’s 510(k) and PMA registries. The manufacturer is based in the United States.
Catalogue
RMU-2000 Automated Chest Compression System Ref K211289
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Defibtech Aed With Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 With Ddp-200P Ref K033896
Regimes: 510(k) Registry: 510(k)Rmu-1000 Automated Chest Compression System Ref K141809
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: PMA Registry: PMA
Company details
- FDA FEI number
- 3003521780
- Address
- 741 BOSTON POST ROAD,SUITE 201, GUILFORD, CT, 06437
FDA recalls
FDA recall records list 20 recalls initiated by Defibtech, LLC, the earliest on 2007-02-17 and the most recent on 2025-03-18. By recorded status: 11 ongoing and 9 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 3
- 2021 0
- 2022 0
- 2023 1
- 2024 5
- 2025 5
- 2026 0
2025
- 18 Mar 2025 Z-1690-2025 Class II Ongoing It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
- 18 Mar 2025 Z-1691-2025 Class II Ongoing It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
- 18 Mar 2025 Z-1692-2025 Class II Ongoing It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
- 18 Mar 2025 Z-1693-2025 Class II Ongoing It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
- 18 Mar 2025 Z-1694-2025 Class II Ongoing It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
2024
- 14 Oct 2024 Z-0502-2025 Class II Ongoing Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.
- 14 Oct 2024 Z-0503-2025 Class II Ongoing Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
- 14 Oct 2024 Z-0504-2025 Class II Ongoing Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
- 14 Oct 2024 Z-0505-2025 Class II Ongoing Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
- 12 Jul 2024 Z-2543-2024 Class I Ongoing Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.
Show all 20 recalls
2023
- 14 Feb 2023 Z-1312-2023 Class II Ongoing A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
2020
- 27 Apr 2020 Z-2392-2020 Class II Terminated A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Full distribution text
- 27 Apr 2020 Z-2393-2020 Class II Terminated A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Full distribution text
- 27 Apr 2020 Z-2394-2020 Class II Terminated A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Full distribution text
- 27 Apr 2020 Z-2392-2020 Class II Terminated A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
2011
- 1 Apr 2011 Z-2064-2011 Unclassified (pre-2012) Terminated Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process
Full distribution text
- 1 Apr 2011 Z-2064-2011 Unclassified (pre-2012) Terminated Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process
2010
- 27 Aug 2010 Z-0077-2011 Unclassified (pre-2012) Terminated Data cards may include an incorrect format which may cause the AED to not function correctly.
- 21 May 2010 Z-1781-2010 Unclassified (pre-2012) Terminated The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
Full distribution text
- 21 May 2010 Z-1782-2010 Unclassified (pre-2012) Terminated The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
Full distribution text
2007
- 17 Feb 2007 Z-0580-2007 Unclassified (pre-2012) Terminated Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
Full distribution text
- 17 Feb 2007 Z-0581-2007 Unclassified (pre-2012) Terminated Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
Full distribution text
- 17 Feb 2007 Z-0580-2007 Unclassified (pre-2012) Terminated Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
Frequently asked questions
How many devices does Defibtech, LLC have in the registry?
The registry currently lists 10 devices for Defibtech, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Defibtech, LLC's devices?
Among its 10 most recently registered devices, Defibtech, LLC has devices listed in FDA 510(k) (9 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Defibtech, LLC's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Defibtech, LLC's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Defibtech, LLC?
FDA recall records list 20 recalls initiated by Defibtech, LLC, the most recent initiated on 2025-03-18. 11 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Defibtech, LLC in the registry?
The most recently registered devices listed for Defibtech, LLC include RMU-2000 Automated Chest Compression System, SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA, DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES and SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES.