The FDA issued a Class I recall for the Brainlab Crainial image-guided surgery system. A Class I recall is the most serious kind issued by the FDA, requiring a manufacturer to take immediate and urgent action to remove affected products from the market. The recall came after problems were reported regarding the navigation display on the device.
The Brainlab Cranial system is used during minimally invasive procedures, and is intended to provide surgeons with images of surgical instrument positioning relative to a patient’s body. However, inaccuracies in the navigation display could cause error during procedures, and lead to potentially fatal injuries.
The Class I recall of this device indicates that the errors within the device’s navigation display have the potential to cause serious adverse health effects, or death, to a patient. The FDA has indicated that more than 1000 units are affected by the recall, which were distributed in eight states including Maryland and Pennsylvania between 1996 and 2015. For more information, read the FDA notice here.
For more information on medical device liability, contact the attorneys at the Law Offices of Peter Angelos.