FDA says Medtronic recalls StealthStation S8 Application

Medtronic is recalling the StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 after customer complaints about a software error causing numbers or letters to be missing from the displayed text and replaced by a space, in either the “distance to target” or “tip stop point” display during navigation, the FDA reports. “The missing digit may result in the mechanical depth stop being set too short or too long and may cause the surgeon to use an incorrect measurement for placement of the biopsy tip stop during navigation. Performing a cranial procedure using incorrect placement could lead to serious permanent injuries, including brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death. Medtronic reports 28 complaints related to this issue. There have been no reported injuries or deaths,” FDA stated.