FDA: Class I recall of Brainlab’s Cranial Image-Guided Surgery System

Editor's Note

The Food and Drug Administration (FDA) on January 15 classified the recall of Brainlab’s Cranial Image-Guided Surgery (IGS) System as Class I, the most serious.

The system is being recalled because of potential inaccuracies in the display by the navigation system compared to the patient’s anatomy. This could lead to inaccurate, ineffective surgical procedures and serious life-threatening injuries, including death.

The recall includes the Cranial IGS and Navigation Systems (all existing versions before Cranial 3.0), distribution dates: May 1996 to May 2015.

Posted 01/15/2016] AUDIENCE: Risk Manager, Surgery ISSUE: Brainlab is recalling the Cranial IGS System due to potential inaccuracies in the display by the navigation system compared to the patient anatomy. This could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death.