BEUDAMED
    FDA Enforcement Class II Terminated

    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.

    Recall: Z-2443-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2443-2021
    Event ID
    88389
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hero Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 22, 2021
    Initiation Date
    July 2, 2021
    Classification Date
    September 10, 2021
    Termination Date
    November 2, 2023
    Address
    20902 Corsair Boulevard, N/A, Hayward, CA, 94545, United States

    Description

    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.

    Reason

    Due to dispenser prompting for a missed dose that had already been dispensed

    Code Info

    Model 100 (H-100) Catalog Number: F00002 Hero 100 V1.4

    Distribution

    U.S. Nationwide distribution.

    Quantity

    12,039 units which had software version V2.04.012