Image-Guided Surgery System Recalled for Navigation Inaccuracies

Updated notices were sent out in May 2015 that Brainlab’s Cranial Image-Guided Surgery (IGS) System had been recalled due to navigation inaccuracies. Ann Marie LaCasha, the director of corporate marketing at Brainlab, said no serious injuries were related to this recall and that the company initiated the process. 

“Brainlab considers patient safety to be our top priority,” she said. “Brainlab Cranial Navigation Systems have been in clinical use for almost 20 years and are safely used in thousands of hospitals worldwide. Hundreds of thousands of patients have significantly benefited from this technology.”

The company, which has a portfolio including technology beyond the cranial navigation system, reports it has been working closely with its customers to update the software associated with the inaccuracies in addition to integrating a new safety feature. “With the FDA reclassifying the recall to Class I, Brainlab is expediting this process,” LaCasha said.  

The Report

The U.S. Food and Drug Administration announced the Class 1 recall for the 1,021 systems that had been distributed in the United States, which included the Brainlab Cranial IGS System and all Brainlab Cranial Navigation Systems prior to the Cranial 3.0, earlier this week. The FDA stated: “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.”

Patients operated on with this technology in the past are considered safe, but the FDA made it clear the potential for patient harm if facilities did not act. Hospitals with this equipment can:

• Direct questions to Brainlab’s customer hotline
• Adhere to the Instructions for Use supplement document entitled “Measures to Improve Cranial Navigation Accuracy”
• Schedule an instillation visit for the necessary software update