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FDA Recalls Brainlab’s Cranial Image-Guided Surgery System

The Food and Drug Administration (FDA) recently issued a Class 1 Recall of Brainlab’s Cranial Image-Guided Surgery (IGS) System due to potential inaccuracies in the navigation display. A Class 1 Recall is the most serious degree issued by the federal agency, and indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

The Brainlab Cranial IGS system provides visualizations for instrument positioning relative to the patient’s anatomy during surgical procedures. Inaccuracies in these visualizations could lead to botched procedures and subsequent injury.  Brainlab first notified system users of the potential navigation inaccuracies in spring 2013.

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, either online or via telephone.

If you have been injured because of a defective product or because of the negligence of another, do not hesitate to contact one of the experienced attorneys at Swartz & Lynch LLP. You may be entitled to compensation for the injuries you have incurred.

 

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