BEUDAMED
    FDA Recall Terminated

    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.

    Recall: Z-2064-2016 · Initiated May 12, 2016

    Recall

    Recall Number
    Z-2064-2016
    Event Number
    74142
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 12, 2016
    Terminated
    December 24, 2018
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.

    Reason

    A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.

    Action

    An Urgent Medical Device Recall Letter was sent to customers on 5/31/16 to inform them that BD had identified an issue with the Alaris System PC unit model 8015 with software versions 9.17 and 9.19. Firm has received reports that a patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. The letter informs the customers of the potential risk and the required action for users. Customers are informed that BD will contact them within 60 days to initiate the scheduling process for the software upgrade installation.

    Distribution

    Distributed US (nationwide) and in Canada.

    Quantity

    69,693 units