The FDA has recalled Brainlab's Cranial Image-guided Surgery (IGS) System due to potential inaccuracies in the display by the navigation system compared to the patient anatomy that could lead to adverse outcomes, life-threatening injuries or death, the agency says.

The class I recall — the most serious type issued by the FDA — indicates that use of all existing versions of Brainlab's Cranial IGS System and Cranial Navigation Systems (before version 3.0) could lead to significant patient harm. Brainlab first notified system users of the potential navigation inaccuracies in April 2013 and sent updated information in May 2015.

Users of the Cranial IGS system are advised to follow supplemental instructions for use entitled "Measures to Improve Cranial Navigation Accuracy." Additionally, Brainlab is in the process of installing software upgrades in the 1,021 systems sold in Arkansas, California, Colorado, Maryland, North Carolina, Ohio, Pennsylvania and Texas.

If you have any questions about the recall, call (800-597-5911) or e-mail Brainlab's customer support hotline.

The FDA asks that you report adverse events or side effects related to the use of the technology.

Daniel Cook