Z-2213-2014Class II

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

Name: Z-2213-2014 Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization...
Creator: Brainlab AG
Published: 2014-05-21
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2014-05-21 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of 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... on 2014-05-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2213-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-21
Posted: 2014-08-13
Terminated: 2017-03-13
Recalling firm: Brainlab, Inc.
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.
Product code: HAW Neurological Stereotaxic Instrument
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
Root cause tag: software
FDA 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 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Model/Catalog Number: 19061-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2213-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2213-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13

Product code HAW

K070106Class IIVv Fluoro 3DBrainlab AG / cleared 2007-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)