Defibtech, LLC — Federal Records

FDA Recall: Defibtech, LLC — Class II 20250507

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product i | Product: Semi-Automated External Defibrillators...

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FDA Device Recall: Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbe 2025-05-07

Class II — 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 ...

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FDA Device Recall: Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1 2025-05-07

Class II — 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 ...

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FDA Device Recall: Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (Ger 2025-05-07

Class II — 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 ...

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FDA Recall: Defibtech, LLC — Class II 20241204

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 t | Product: Defibtech DDP-2001: Adult Defibrillati...

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FDA Device Recall: Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline 2024-12-04

Class II — 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 unau...

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FDA Device Recall: RMU-2000 Automated Chest Compression Device 2024-08-21

Class I — 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.

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FDA Device Recall: DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on vic 2023-04-05

Class II — 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 therap...

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FDA Recall: Defibtech, LLC — Class II 20200624

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 | Product: DDU-2450 Lifeline ECG Model Numbers...

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FDA Device Recall: DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DD 2020-06-24

Class II — 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.

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FDA Device Recall: DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A230 2020-06-24

Class II — 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.

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FDA Device Recall: DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External 2020-06-24

Class II — 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.

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