BEUDAMED
    FDA Recall Open, Classified

    Fisher Wallace Stimulator Models FW-100 and FW-200

    Recall: Z-1600-2023 · Initiated April 6, 2023

    Recall

    Recall Number
    Z-1600-2023
    Event Number
    91982
    Firm
    Fisher Wallace Laboratories Inc.
    FEI Number
    3006258094
    Product Code
    QJQ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 6, 2023
    Posted
    May 17, 2023
    Address
    630 Flushing Ave, Ste 104, Brooklyn, NY, 11206-5775

    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.

    Action

    An URGENT MEDICAL DEVICE CORRECTION dated 4/6/23 was sent to customers. Short term actions to be taken by the User: 1. Always ensure the batteries are inserted correctly into the device (see above diagram). 2. Do not leave batteries in the device when the device is not in use (e.g. in between a morning and evening treatment). 3. Do not fall asleep while using the device because corrective actions cannot be taken when the user is asleep. 4. If the device exhibits excess heat, burning smell, or odor, turn off the device, and discontinue use. Contact Fisher Wallace Laboratories immediately. The long term corrective action by the company is still being determined. We request your action by replying to this email to confirm that you understand the information in this medical device correction and the subsequent actions needed to be taken. Fisher Wallace apologizes for any inconvenience this may cause. If you have any questions about what to do with your product, please contact Fisher Wallace by telephone Monday - Friday, 10:00 AM to 6:00 PM, Eastern Time at (800) 692-4380 or by email at [email protected].

    Distribution

    US Nationwide. Global Distribution.

    Quantity

    43,489 total devices