BEUDAMED
    FDA Enforcement Class II Ongoing

    Fisher Wallace Stimulator Models FW-100 and FW-200

    Recall: Z-1600-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1600-2023
    Event ID
    91982
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fisher Wallace Laboratories Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 24, 2023
    Initiation Date
    April 6, 2023
    Classification Date
    May 17, 2023
    Address
    630 Flushing Ave Ste 104, N/A, Brooklyn, NY, 11206-5775, United States

    Description

    Fisher Wallace Stimulator Models FW-100 and FW-200

    Reason

    If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.

    Code Info

    FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T

    Distribution

    US Nationwide. Global Distribution.

    Quantity

    43,489 total devices