FDA-Device2025-07-02Class II
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.
Jolife AB
Hazard
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
Sold states
U.S. Nationwide distribution in the states of IN, MI, OH and TX.
Affected count
5 units
Manufactured in
Scheelevagen 17, Ideon Science Park, Lund, Sweden
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1998-2025Don't want to check this manually?
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