BEUDAMED
    FDA Enforcement Class II Terminated

    BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.

    Recall: Z-0967-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0967-2014
    Event ID
    67017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2014
    Initiation Date
    November 15, 2013
    Classification Date
    February 10, 2014
    Termination Date
    March 13, 2017
    Address
    Kapellenstrasse 12, N/A, Feldkirchen, N/A, N/A, Germany

    Description

    BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.

    Reason

    Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirect

    Code Info

    Model/Catalog Code: 55830-25A Instrument Star Unit ML; Serial Numbers (US Devices): 1205112007, 1205112010, 1205112011, 1205112013, 1205112014, 1205112019, 1205112021, 1205112029, 1205112034, 1205112045; Serial Numbers (Non-US Devices): 1205112004, 1205112006, 1205112008, 1205112009, 1205112015, 1205112016, 1205112017, 1205112018, 1205112020, 1205112023, 1205112025, 1205112026, 1205112027, 1205112030, 1205112032

    Distribution

    Worldwide Distribution - USA including CA, MN, NC, NY, OH, TX and DC. Internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, United Arab Emirates.

    Quantity

    25 units