The U.S. Food and Drug Administration (FDA) has puts its most serious Class I label on a recall of Brainlab’s Image-Guided Surgery (IGS) System. According to an FDA recall notification, the system was recalled due to potential inaccuracy. Class I recalls indicate that exposure to the recalled device presents a reasonable risk of injury or death.
The Brainlab Cranial IGS System is used during minimally invasive surgeries to show where the instrument is relative to the patient’s anatomy. However, the recall notice states that the display may not be accurate and lead to serious, potentially fatal 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.
The recalled systems were distributed in the United States from May 1996 to May 2015; 1021 units are affected nationwide. Customers were notified of the issue in April 2013. In May 2015, an update was issued 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.”