Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to en

FDA device recall Z-2213-2014 · posted 2014-08-13 · Terminated

Recall details

Recalling firm

Brainlab AG

Reason for recall

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

Action taken

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 communication from automatic to manual to enable a safe and effective usage of this device combination, and 4) advise the appropriate personnel working in your department of the content of the letter. Customers with any questions can contact Brainlab via telephone at 800-597-5911 or e-mail at us.support@brainlab.com.

Root cause

Software in the Use Environment

Status

Terminated

Product code

HAW

Quantity affected

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.

Date initiated

2014-05-21

Date posted

2014-08-13

Date terminated

2017-03-13

Location

Feldkirchen, Germany

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