News & Research

FDA issues Class I recall over software used in Medtronic brain surgery.

Four different versions of Medtronic’s StealthStation S8 application, intended for use with a surgical drill, were subject to a Class I recall, the most serious kind of recall, following customer complaints about a software error that resulted in numbers or letters missing from the displayed text and being replaced by a space. This could lead to the surgeon placing the biopsy tip stop during navigation in neurosurgery using the wrong measurement.