BEUDAMED
    FDA Enforcement Class II Completed

    AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

    Recall: Z-0220-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0220-2025
    Event ID
    95414
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Ad-Tech Medical Instrument Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 30, 2024
    Initiation Date
    September 19, 2024
    Classification Date
    October 24, 2024
    Address
    400 W Oakview Pkwy, N/A, Oak Creek, WI, 53154-7213, United States

    Description

    AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

    Reason

    Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.

    Code Info

    UDI/DI 00841823107589, Lot Number 169260 858859860, 169258 858859860

    Distribution

    US Nationwide distribution in the states of CA, OH.

    Quantity

    4 units