BEUDAMED
    FDA Recall 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 · Initiated July 3, 2019

    Recall

    Recall Number
    Z-2081-2019
    Event Number
    83342
    Firm
    Xcision Medical Systems, LLC
    FEI Number
    3014273653
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 3, 2019
    Terminated
    July 1, 2021
    Address
    9176 Red Branch Rd, Ste O, Columbia, MD, 21045-2001

    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.

    Action

    The firm sent a Field Correction Notice letters dated 7/3/19 to customers. The letter identified the affected product, problem and actions to be taken. If you need any further information or support concerning this issue, please contact Xcsion Customer Support at 855-924-7466.

    Distribution

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

    Quantity

    2