BEUDAMED
    FDA Recall Open, Classified

    AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

    Recall: Z-0221-2025 · Initiated September 19, 2024

    Recall

    Recall Number
    Z-0221-2025
    Event Number
    95414
    Firm
    Ad-Tech Medical Instrument Corporation
    FEI Number
    2183456
    Product Code
    GZL
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    September 19, 2024
    Posted
    October 24, 2024
    Address
    400 W Oakview Pkwy, Oak Creek, WI, 53154-7213

    Description

    AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-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.

    Action

    AD-TECH issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/19/2024. The notice explained the problem with the devices, risk to health, and requested the consignee contact customer support to obtain an RMA to expedite the return of the affected product. For questions: contact your Ad-Tech Clinical Specialist.

    Distribution

    US Nationwide distribution in the states of CA, OH.

    Quantity

    14 units