BEUDAMED
    FDA Recall Completed

    Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

    Recall: Z-0462-2019 · Initiated September 24, 2018

    Recall

    Recall Number
    Z-0462-2019
    Event Number
    81092
    Firm
    Invivo Corporation
    FEI Number
    1051786
    Product Code
    DQK
    Status
    Completed
    Root Cause
    Software Design Change
    Initiated
    September 24, 2018
    Address
    12151 Research Pkwy, Ste 200, Orlando, FL, 32826-3286

    Description

    Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

    Reason

    The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard

    Action

    Customers were notified on about 09/20/2018 via an "URGENT - Medical Device Correction" letter. An initial letter was sent to distributors with instructions to provide the Field Safety Notice to all customers the devices were further distributed to. The "URGENT - Medical Device Correction" letter provided guidance on how to identify the Service Number and serial number on the Flex Cardio device, which is on the bottom right corner of the back of the device. Actions to be taken by the customer/user until Philips contacts the customer to arrange for a software update to address this issue, is if the IBP numeric values become frozen and do not update in real-time, opening the Waveform Setup Dialog and then immediately pressing the OK button will restore the proper display of the IBP numeric values. Alternative methods of performing the functions listed in the Problem Description section that do not cause the problem to occur include the following: 1. Change an IBP Site Label using the Pressure Setup Dialog or a macro; 2. Activate or deactivate the mean pressure waveform display option (On/Off) by using the Waveform Setup Dialog, the Pressure Setup Dialog or a macro; 3. Activate or deactivate the waveform hide option (On/Off) using the Waveform Setup Dialog, the Pressure Setup Dialog, the keyboard or a macro; 4. Activate or deactivate the pressure waveform filter option (On/Off) using a macro. A Philips representative will contact each customer regarding their affected Flex Cardio devices. A software update will be required on both the affected Flex Cardio device and on the host workstations driver. These actions will be implemented free of charge by Philips.

    Distribution

    Distributed to the Netherlands

    Quantity

    76 units