BEUDAMED
    FDA Recall Terminated

    Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081

    Recall: Z-0614-2019 · Initiated November 15, 2018

    Recall

    Recall Number
    Z-0614-2019
    Event Number
    81527
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    November 15, 2018
    Terminated
    September 20, 2024
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081

    Reason

    There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.

    Action

    The firm initiated the recall on X by letter. The letter explained the issues, potential risk, and provided workarounds for the consignee to use until the new software is ready for release.

    Distribution

    worldwide

    Quantity

    651 units