BEUDAMED
    FDA Enforcement Class I Ongoing

    SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

    Recall: Z-2103-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2103-2023
    Event ID
    92562
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2023
    Initiation Date
    June 15, 2023
    Classification Date
    July 13, 2023
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

    Reason

    A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

    Code Info

    GTIN 00085412498683, Software version v8.01.01, Serial Numbers

    Distribution

    US Nationwide distribution.

    Quantity

    3306 units