Recall Z-1312-2023— Defibtech, LLC

Name: FDA recall Z-1312-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-14

Class II · Ongoing

Class II FDA medical device recall by Defibtech, LLC, initiated 2023-02-14. FDA's recall record names no specific 510(k) clearance for this event. Product: DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest. Reason: 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..

Recalling firm: Defibtech, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-02-14
Firm location: Guilford, CT, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.