Recall Z-2393-2020— Defibtech, LLC

Name: FDA recall Z-2393-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-27

Class II · Terminated

Class II FDA medical device recall by Defibtech, LLC, initiated 2020-04-27, terminated 2021-01-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm: Defibtech, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-27
Terminated: 2021-01-08
Firm location: Guilford, CT, United States

Product description

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.

Reason for recall

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.

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