BEUDAMED
    FDA Recall Open, Classified

    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

    Recall: Z-0227-2025 · Initiated September 25, 2024

    Recall

    Recall Number
    Z-0227-2025
    Event Number
    95484
    Firm
    Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden
    FEI Number
    3002806883
    Product Code
    HAW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 25, 2024
    Posted
    November 6, 2024

    Description

    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

    Reason

    Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.

    Action

    Elekta issued an URGENT IMPORTANT FIELD SAFETY NOTIFICATION to its consignees on 069/23/2023 via email. Then notice explained the problem, clinical impact, and requested the destruction of the affected product. Contact the local Elekta representative for alternative solutions. They also requested that the notice be posted in a place accessible to all users until this action is closed and to notify all appropriate personnel working with this product of the content of the notice.

    Distribution

    US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,

    Quantity

    111 kits (666 needles)