Medical device recalls Moderate risk

Jolife AB recalls LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult p…

Recall date
May 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1998-2025
FDA classification
Class II
Brand / firm
Jolife AB
Sold / distributed
U.S. Nationwide distribution in the states of IN, MI, OH and TX.

Why it was recalled

Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.

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

What was recalled

LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

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