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FDA Places Most Serious Recall Status on Brainlab Cranial IGS System Recall

Filed January 20th, 2016 Lillian Chiu

The U.S. Food and Drug Administration (FDA) has given a Class I designation to Brainlab’s recall of its Image-Guided Surgery (IGS) System. The Brainlab Cranial IGS System shows surgeons where their instruments are relative to the patient’s anatomy during minimally invasive surgeries. The recall was issued because the display may be inaccurate, potentially leading to serious or life-threatening consequences.

“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.” the notification states. Class I recalls are the most serious type of recall indicating that the recalled device may present risk of serious injury or death.

The Cranial IGS Systems were distributed in the United States from May 1996 to May 2015. According to the notification, 1021 units are affected nationwide.

Brainlab first notified customers of the issue in April 2013. An update was issued in May 2015, stating “Customers should adhere to the Instructions for Use supplement document “Measures to Improve Cranial Navigation Accuracy” when using the affected product.” Brainlab also said it would “provide customers with an updated software version and schedule the update installation starting in September 2015.”

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