FDA recall Z-1998-2025

Jolife AB · Class II · device

Product

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.

Reason for recall

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

Distribution

U.S. Nationwide distribution in the states of IN, MI, OH and TX.

Key facts

Status
Ongoing
Initiation date
2025-05-21
Report date
2025-07-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lund, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1998-2025