BEUDAMED
    FDA Enforcement Class II Ongoing

    GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

    Recall: Z-0750-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0750-2024
    Event ID
    93684
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Xcision Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 24, 2024
    Initiation Date
    November 30, 2023
    Classification Date
    January 18, 2024
    Address
    9176 Red Branch Rd Ste O, N/A, Columbia, MD, 21045-2001, United States

    Description

    GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

    Reason

    Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

    Code Info

    00850002615029(11)230321(21)TPS0018 (Distributed in the US) 00850002615029(11)230629(21)TPS0013 (Distributed in the US) 00850002615005(11)21H24(21)TPS0016 (Distributed in the US) 00850002615029(11)210629(21 )TPS0014 (Italy)

    Distribution

    Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.

    Quantity

    4 units