BEUDAMED
    FDA Enforcement Class II Ongoing

    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

    Recall: Z-3099-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3099-2024
    Event ID
    95160
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zoe Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2024
    Initiation Date
    August 13, 2024
    Classification Date
    September 10, 2024
    Address
    460 Boston St, Topsfield, MA, 01983-1223, United States

    Description

    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

    Reason

    This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.

    Code Info

    Model No. 91331-M; UDI-DI 00851920007347; all serial numbers up to GFD10486 Model No. 91331-MF; UDI-DI 00851920007354; all serial numbers up to GFD10486 Model No. 91331-N; UDI-DI 00851920007309; all serial numbers up to GFD10486 Model No. 91331-NF; UDI-DI 00851920007316; all serial numbers up to GFD10486 Model No. 91331-MW; UDI-DI 00851920007361; all serial numbers up to GFD10486 Model No. 91331-MFW; UDI-DI 00851920007378; all serial numbers up to GFD10486 Model No. 91331-NW; UDI-DI 00851920007323; all serial numbers up to GFD10486 Model No. 91331-NFW; UDI-DI 00851920007330; all serial numbers up to GFD10486

    Distribution

    awaiting additional details

    Quantity

    1506 units