Defibtech Recalls 860 Lifeline PRO AEDs Due to Shock Delivery Failure
Defibtech is recalling 860 Lifeline PRO AEDs because a component issue may cause the device to abort or fail 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a life-saving medical device (AED) that may fail to deliver a shock during sudden cardiac arrest, posing a significant risk of harm.
Plain-English summary
Defibtech, LLC is recalling 860 units of the DDU-2400EN Lifeline PRO Automated External Defibrillator (AED). The recall is limited to devices with Serial Number 400101322. These devices were distributed worldwide, including in the United States, Australia, Canada, France, Malaysia, Mauritius, the Netherlands, Thailand, and the United Arab Emirates.
The recall is being issued because a component issue may cause the AED to abort a shock delivery or reset unexpectedly. This malfunction may cause the device to fail to deliver a shock or fail to deliver a shock within the required range.
Consumers and healthcare facilities should stop using the affected devices immediately and contact Defibtech, LLC for instructions on repair or replacement.
The recalled product
- Product
- DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
- Manufacturer
- Defibtech, LLC
- Affected units
- 860
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number 400101322
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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