Medical technology company Brainlab has recalled the Brainlab Cranial IGS (Image Guided Surgery) System because inaccuracies in the navigation system display could lead to inaccurate medical procedures that could result in life-threatening injuries and death.
The Food and Drug Administration (FDA) has categorized this as a Class I recall, the most serious type of recall. Use of the Brainlab Cranial IGS System may cause serious injury or death.
Brainlab Cranial IGS System shows the surgeon the area of interest and the position of an instrument relative to the patient’s anatomy to enable minimally invasive surgical procedures. The surgeon is guided through the procedure, helping to keep skull openings small and minimizing damage to healthy structures, the company says.
Brainlab Notified Customer About the Issue
The recall includes about 1021 units distributed nationwide from May 1996 to May 2015. All existing versions of the cranial navigation system before Cranial 3.0 are included in the recall.
Brainlab notified customers of the issue on April 22, 2013 and issued an update on May 29, 2015. The recall notice was updated on January 15, 2016. In a notification to customers, Brainlab said customers should adhere to the Instructions for Use supplement document “Measures to Improve Cranial Navigation Accuracy” when using the affected product.
Brainlab will provide customers with an updated software version and schedule the update installation starting in September 2015.
Customers can contact the Brainlab Customer Hotline at 1-800-597-5911 or can send email to support@Brainlab.com.