BEUDAMED
    FDA Enforcement Class II Terminated

    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

    Recall: Z-3192-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3192-2018
    Event ID
    80761
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invivo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    August 3, 2018
    Classification Date
    September 18, 2018
    Termination Date
    July 15, 2021
    Address
    12151 Research Pkwy Ste 200, N/A, Orlando, FL, 32826-3286, United States

    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.

    Code Info

    System Serial Numbers: US1814000001, US1814000002, US1814000003, US1814000004, US1814000006, US1814000007, US1814000008, US1814000011, US1814000012, US1814000013, US1814000014, US1814000016, US1814000017, US1814000018, US1814000019, US1814000020, US1814000022, US1814000023, US1814000024, US1814000027, US1814000028, US1814000030, US1814000031, US1814000032, US1814000033, US1814000034, US1814000037, US1814000044, US1814000046, US1814000050, US1814000053, US1814000062, US1814000066, US1814000068,and US1814000072

    Distribution

    Distribution in the Netherlands

    Quantity

    38