BEUDAMED
    FDA Enforcement Class II Terminated

    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

    Recall: Z-2083-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2083-2013
    Event ID
    65773
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 16, 2013
    Classification Date
    August 26, 2013
    Termination Date
    March 13, 2017
    Address
    Kapellenstrasse 12, Feldkirchen, N/A, Germany

    Description

    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

    Reason

    The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.

    Code Info

    Part No. 43410

    Distribution

    Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.

    Quantity

    6 units