BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-1998-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-1998-2025
    Event ID
    96729
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Jolife AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2025
    Initiation Date
    May 21, 2025
    Classification Date
    June 20, 2025
    Address
    Scheelevagen 17, Ideon Science Park, Lund, N/A, Sweden

    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.

    Reason

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

    Code Info

    Lucus 2 Catalog Number: 99576-000025 UDI-DI code: 00883873904565 Serial Number: 30090111 Lucas 3 Catalog Number: 21331-000081 UDI-DI code: 00883873861875 Serial Numbers: 35172335 35160570 Lucas 3.1 Catalog Number: 94576-000005 UDI-DI code: 00883873834329 Serial Numbers: 3518A164 3518D104 (Scrapped)

    Distribution

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

    Quantity

    5 units