BEUDAMED
    FDA Recall 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 · Initiated July 16, 2013

    Recall

    Recall Number
    Z-2083-2013
    Event Number
    65773
    Firm
    Brainlab AG Kapellenstrasse 12 Feldkirchen Germany
    FEI Number
    3002619595
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 16, 2013
    Posted
    August 26, 2013
    Terminated
    March 13, 2017

    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.

    Action

    BrainLab sent an "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" dated July 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the SRS QA Target Pointer. Consignees can instead use the Phantom Pointer feature until Brainlab can provide replacement hardware. Brainlab anticipates being able to provide all impacted facilities with replacement hardware by the end of July 2013. We sincerely apologize for any inconvenience and thank you in advance for your co-operation. If you require further clarification, please feel free to contact your local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by E-mail: [email protected]. Fax Brainlab AG: + 49 89 99 15 68 33

    Distribution

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

    Quantity

    6 units