BEUDAMED
    FDA Recall Terminated

    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

    Recall: Z-0107-2019 · Initiated September 18, 2018

    Recall

    Recall Number
    Z-0107-2019
    Event Number
    81158
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1314492
    Product Code
    PHC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 18, 2018
    Terminated
    August 19, 2020
    Address
    711 Park Ave, Medina, NY, 14103-1036

    Description

    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

    Reason

    If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.

    Action

    The firm initiated their field correction by email on 09/14/2018. The notice alerted the consignee of the problem and stated that Baxter would be issuing a software update to correct the issue.

    Distribution

    NJ

    Quantity

    354 units