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FDAApril 27, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

defibtech

UPCs

00815098020270

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear