Defibtech Lifeline ECG AEDs Recalled for Potential Shock Delivery Failure
Defibtech is recalling 860 Lifeline ECG Automated External Defibrillators because a component issue may cause the device to abort or reset, potentially failing to deliver a shock.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a life-saving device failing to deliver a shock during cardiac arrest, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Defibtech, LLC is recalling 860 units of the DDU-2450 Lifeline ECG Automated External Defibrillator (AED). The affected models include DDU-A2450EN, DDU-E2450DE, DDU-E2450EN, DDU-E2450FR, and DDU-E2450TH, with catalog numbers DCF-A2460EN, DCF-A2463EN, DCF-E2460DE, DCF-E2460EN, DCF-E2460FR, and DCF-E2460TH. The devices are identified by specific serial numbers listed in the recall notice and UDI codes 00815098020287 and 00815098020317.
The recall is due to a component issue that may cause the AED to abort a shock delivery or reset unexpectedly. This malfunction could result in the device failing to deliver a shock or failing to deliver a shock within the required range. AEDs are indicated for use on victims of sudden cardiac arrest who are unconscious, unresponsive, and not breathing or not breathing normally.
The affected units were distributed worldwide, including nationwide in the United States and in Australia, Canada, France, Malaysia, Mauritius, the Netherlands, Thailand, and the United Arab Emirates. Users should check their device serial numbers against the provided list to determine if their unit is affected.
The recalled product
- Product
- 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…
- Manufacturer
- Defibtech, LLC
- Affected units
- 860
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Defibtech, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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