FDA Issues Class I Recall on Cranial Surgery System Due to Software Error

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) has announced a Class I recall on Medtronic’s Stealthstation S8, a cranial surgery system, for a software error on Wednesday.

Class I recall is the most serious type of recall, use of these devices may cause serious injuries or death, according to the FDA.