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Navigation Spine & Trauma 3D Version 2.0 and 2.1 recallZ-2213-2014 · Brainlab AG · initiated May 21, 2014

Class II Terminated All recalls posted in August 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Brainlab AG or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software in the Use Environment

What the company is doing

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].

Recall details

Recall number
Z-2213-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 21, 2014
Posted by the FDA
Aug 13, 2014
Recalling firm
Brainlab AG
Quantity
17 systems
Product code
HAW
FDA submissions
K070106
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 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.

Code information (models, lots, serial numbers)

Model/Catalog Number: 19061-03

Other devices under the same FDA submission

1 device cleared under K070106 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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