Recall Z-2213-2014 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
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 stereo
| Date | Aug 13, 2014 (initiated May 21, 2014) |
| Status | Terminated |
| 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 " |
| Root cause | Software in the Use Environment |
| Action | The firm, Brainlab AG, sent "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letters dated May 21, 2014 to all consignees. The letters included instructions for consignees to: 1) not use Automatic Registration of iCT Data in combination with Siemens SOMATOM Definition AS CT scan (with Software Somaris SOM 7 or higher and Automatic Gantry Communication (available for Spine & Trauma 3D 2.0 and 2.1 only); 2) always make sure to perform careful accuracy verification according to the instructions in the Software User Guide; 3) Brainlab will perform corresponding service visits to change the gantry comm |
| Quantity | 17 systems |
| Distribution | Worldwide distribution: US (nationwide) including states of: NC, NY, OH, WI;and countries of: Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070106 | VV FLUORO 3D Brainlab AG, Apr 23, 2007 |