BEUDAMED
    FDA Recall Terminated

    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

    Recall: Z-3192-2018 · Initiated August 3, 2018

    Recall

    Recall Number
    Z-3192-2018
    Event Number
    80761
    Firm
    Invivo Corporation
    FEI Number
    1051786
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    August 3, 2018
    Terminated
    July 15, 2021
    Address
    12151 Research Pkwy, Ste 200, Orlando, FL, 32826-3286

    Description

    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

    Reason

    Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.

    Action

    Philips is asking customers to follow the Action to be Taken by Customer/User section of the August 3, 2018, Field Safety Notice: The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will replace all affected devices. Users should discontinue use of affected devices immediately. A Philips representative will contact you regarding your affected device.

    Distribution

    Distribution in the Netherlands

    Quantity

    38