BEUDAMED
    FDA Recall Terminated

    Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.

    Recall: Z-2110-2021 · Initiated June 4, 2021

    Recall

    Recall Number
    Z-2110-2021
    Event Number
    88073
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 4, 2021
    Posted
    August 6, 2021
    Terminated
    September 25, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.

    Reason

    System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.

    Action

    Baxter initiated the recall by letter on 06/04/2021. The letter described the problem and the hazard involved, and requested the consignee Baxter Technical Assistance in advance of making changes to your network or server infrastructure supporting the pumps or the Baxter Gateway, as indicated in Baxter's Gateway Server Installation Handoff document which customers receive upon installation. The firm is developing a software patch for all Spectrum IQ infusion pumps.

    Distribution

    United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.

    Quantity

    130135 units