BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1091-2022
    Event ID
    89843
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Neuralynx Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2022
    Initiation Date
    March 14, 2022
    Classification Date
    May 13, 2022
    Address
    105 Commercial Dr, N/A, Bozeman, MT, 59715, United States

    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.

    Code Info

    ASHB Part No. 31-0601-0077 (SN0001, SN0002, SN0004, SN0005, SN0006, SN0007, SN0008, SN0009, SN0010, SN0012); ASHB Part No. 31-0601-0132(SN0003, SN0005, SN0006); ASHB Part No. 31-0601-0089(SN0004, SN0006);

    Distribution

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

    Quantity

    15