Company: Brainlab AG.
Date of Enforcement Report: 8/27/2014
Class lI:
PRODUCT
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 Number Z-2213-2014
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 “table-zero-position” is sent from the CT scanner to the Brainlab navigation software in a special format. Due to a change in the corresponding Siemens data output, the information from the CT scanner cannot be correctly processed in the navigation software, when using: 1) Automatic Registration of iCT Data, in combination with 2) Siemens SOMATOM Definition AS CT scanner with Software Somaris SOM 7 (or higher), and 3) Automatic Gantry Communication (available for Spine & Trauma 3D 2.0 and 2.1 only). As a result, in the navigation software the CT image data set appears shifted in the scanner movement direction (patient head-feet direction). The scale of the shift can differ in each scan, varying from sub-millimeters to meters.
RECALLING FIRM/MANUFACTURER
Brainlab AG , Feldkirchen, DE on 5/21/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
17 systems
DISTRIBUTION
Nationwide and Internationally
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