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Defibtech, LLC recalls DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Recalled April 5, 2023 · FDA recall Z-1312-2023 · Defibtech
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. · FDA Class II
Units
29 units
Sold at
US Nationwide distribution.
Description
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.
Product
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Manufacturer(s)
Defibtech, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →