BEUDAMED
    FDA Enforcement Class II Terminated

    BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.

    Recall: Z-2479-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2479-2020
    Event ID
    85233
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Preventice Services, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 8, 2020
    Initiation Date
    August 6, 2019
    Classification Date
    July 1, 2020
    Termination Date
    November 18, 2022
    Address
    1717 N Sam Houston Pkwy W Ste 100, N/A, Houston, TX, 77038-1324, United States

    Description

    BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.

    Reason

    The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidated association between the phone software and the heart monitors, therefore, the patient's report should not be used to evaluate their condition.

    Code Info

    Version 2.3 phone software, kit IDs BG2570727, BG2565845, BG2567817, BG2566832, BG2566830, BG2570699, BG2566530, and BG2570700.

    Distribution

    US Nationwide Distribution to AK, AL, GA, NJ, OH, and TX. There was no foreign/military/government distribution.

    Quantity

    8 kits