BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A

    Recall: Z-2052-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2052-2026
    Event ID
    98722
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Spacelabs Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    March 26, 2026
    Classification Date
    May 1, 2026
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216, United States

    Description

    Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A

    Reason

    Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

    Code Info

    Model/Catalog Number: 91496 UDI-DI Code: (01)10841522106422 Serial Numbers: 1496-224669 1496-224670 1496-224657 1496-224658 1496-224659 1496-224660 1496-224661 1496-224671 1496-224673 1496-224674 1496-224675 1496-224676 1496-224677 1496-224678 1496-224679 1496-224680 1496-224681 1496-224682 1496-224683 1496-224684 1496-224685 1496-224686 1496-224687 1496-224688 1496-224689 1496-224690 1496-224691 1496-224692 1496-224693 1496-224694 1496-224695 1496-224696 1496-224697 1496-224698 1496-224699 1496-224701 1496-224702 1496-224703 1496-224704 1496-224705 1496-224706 1496-224707 1496-224708 1496-224709 1496-224710 1496-224711 1496-224712 1496-224713 1496-224714 1496-224715 1496-224716 1496-224664 1496-224665 1496-224666 1496-224667 1496-224668

    Distribution

    Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA.

    Quantity

    57