BEUDAMED
    FDA Recall Open, Classified

    ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.

    Recall: Z-1091-2022 · Initiated March 14, 2022

    Recall

    Recall Number
    Z-1091-2022
    Event Number
    89843
    Firm
    Neuralynx Inc
    FEI Number
    3009391672
    Product Code
    GXY
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    March 14, 2022
    Address
    105 Commercial Dr, Bozeman, MT, 59715

    Description

    ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.

    Reason

    Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.

    Action

    Customer notifications were sent out to all affected customers on March 14, 2022, via USPS certified mail. Actions to be taken: Field representatives will be contacting consignees to return the effected product and coordinate a replacement with their cleared headbox, product models 31-0601-0007, 31-0601-0010 or 31-0601-0017, by April 6, 2022. In the interim, it is advised to stop use of this product. Any further questions regarding this matter, contact by email at [email protected] or by telephone at 207-666-5425 Monday -Friday 8:00 AM -4:30 PM EST.

    Distribution

    U.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.

    Quantity

    15