BEUDAMED
    FDA Enforcement Class II Terminated

    GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device 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-2081-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2081-2019
    Event ID
    83342
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Xcision Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    July 3, 2019
    Classification Date
    July 25, 2019
    Termination Date
    July 1, 2021
    Address
    9176 Red Branch Rd, Ste O, Columbia, MD, 21045-2001, United States

    Description

    GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device 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

    One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

    Code Info

    Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005

    Distribution

    The products were distributed to the following US states: MD and TX.

    Quantity

    2