BEUDAMED
    FDA Enforcement Class II Terminated

    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable 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 or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic 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 the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

    Recall: Z-2213-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2213-2014
    Event ID
    68845
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    May 21, 2014
    Classification Date
    August 13, 2014
    Termination Date
    March 13, 2017
    Address
    Kapellenstrasse 12, N/A, Feldkirchen, N/A, N/A, Germany

    Description

    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable 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 or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic 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 the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

    Reason

    Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the gantry position of the scanner. The gantry position can either be entered manually or submitted automatically from the CT scanner. If automatic gantry communication is available, the so-called &quot

    Code Info

    Model/Catalog Number: 19061-03

    Distribution

    Worldwide distribution: US (nationwide) including states of: NC, NY, OH, WI;and countries of: Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia.

    Quantity

    17 systems