BEUDAMED
    FDA Enforcement Class II Ongoing

    Ultraview SL (UVSL) Command Module, Model 91496

    Recall: Z-1503-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1503-2023
    Event ID
    91851
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Spacelabs Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2023
    Initiation Date
    April 12, 2023
    Classification Date
    May 3, 2023
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216, United States

    Description

    Ultraview SL (UVSL) Command Module, Model 91496

    Reason

    Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.

    Code Info

    Software version 2.03.06 and earlier and software version 2.04 and later.

    Distribution

    US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR, TX, GA, IL, OK, SC, PA, AL, KS, FL, ID, MI, MN, IA, NJ, MD, VA, AR, CT, NE, LA, AK, MS, ME, WV, NY, AZ, TN, WY, IN, MA, MT, CO, DE, ND, WI, NV, RI, NH, UT.

    Quantity

    1,088