Unreliable Imaging Software in Brainlab Product Prompts Recall
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Unreliable Imaging Software in Brainlab Product Prompts Recall

January 18, 2016

A surgical aid manufactured by Brainlab is being recalled due to potential defects in its display system.

In cooperation with the Food and Drug Administration (FDA), the German company is recalling its Brainlab Cranial Image-Guided Surgery (IGS) System. The device is intended to produce images of the patient's anatomy to enable minimally invasive surgical procedures. However, the attached display system can produce inaccuracies compared to the true anatomy of the patient.

This could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries, including death.

Brainlab distributed the defective devices from May 1996 through May 2015. A total of 1,021 units were distributed to locations in Arkansas, California, Colorado, Maryland, North Carolina, Ohio, Pennsylvania, and Texas.

The company recommends that users adhere to the Instructions for Use supplement document "Measures to Improve Cranial Navigation Accuracy" when using the affected product. Brainlab began providing customers with an updated version of the defective software in September 2015.

Customers with questions about this recall can contact the Brainlab Customer Hotline by phone at (800) 597-5911 or by email at support@brainlab.com.