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FDAFebruary 14, 2023device

DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

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

The hazard

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 therapy.

What to do

FDA enforcement status: Ongoing

Brands named

defibtech

UPCs

00815098020003

Recall history

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

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