Defibtech, LLC recalls DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for…

Recall date

April 27, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2393-2020

FDA classification

Class II

Brand / firm

Defibtech, LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.