Jolife AB: Device Recall

Recall #Z-1998-2025 · 05/21/2025

Class II: Risk

Recall Details

Recall Number
Z-1998-2025
Classification
Class II
Product Type
Device
Recalling Firm
Jolife AB
Status
Ongoing
Date Initiated
05/21/2025
Location
Lund, Sweden
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Reason for Recall

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

Product Description

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.

Distribution Pattern

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.