Class I Recall of Brainlab 3D Surgical Navigation Software

Megan Brooks

April 16, 2019

Brainlab has recalled the 3D navigation software used with the company's Spine & Trauma Navigation System due to the potential for inaccurate information to display that may prevent the surgeon from accurately navigating surgical tools during surgery.

This is a class I recall — the most serious type — due to the potential for serious patient injury or death, the US Food and Drug Administration (FDA) said. 

The software for the Brainlab Spine & Trauma 3D Navigation System provides patient images to help surgeons safely navigate surgical tools and implants used before and during minimally invasive surgical procedures. 

The recalled software is version 1.0 and was manufactured and distributed between May 2018 and February of this year.  Brainlab notified customers of the problem on March 1 and provided the following advice:

  • Avoid workflow changes with already registered datasets, if possible. For intraoperative screw planning, avoid switching between the workflow application selections "3D Navigation Intraoperative Imaging" and "3D Navigation" during one patient treatment.

  • After restarting the application with a previously registered dataset (crash restore or workflow change), always activate and deactivate the sub-menu "Orientation" once to ensure that the correct, expected view representations are displayed for the current session.

  • Continue to follow instructions and warnings in the user guide, particularly regarding maintaining navigation accuracy and avoiding reference displacement.

Brainlab plans to stop distributing the software and will release an updated version. Healthcare professionals and distributors in the US with questions should call 1-800-597-5911 or email us.support@brainlab.com.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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