Defibtech DDU-2300 AED Recalled for Potential Shock Delivery Failure
Defibtech is recalling 860 DDU-2300 AEDs because a component issue may cause the device to abort or fail to deliver a shock.
What this means for you
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-2300 Lifeline/ReviveR View Automated External Defibrillator (AED). The affected model numbers include DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, and DDU-E2300EN, along with specific catalog and UDI numbers listed in the official recall notice.
The recall is due to a component issue that may cause the AED to abort a shock delivery or reset unexpectedly. This defect may 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 normally.
The affected devices were distributed worldwide, including in the United States, Australia, Canada, France, Malaysia, Mauritius, the Netherlands, Thailand, and the United Arab Emirates. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- 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, 00815098020
- 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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