Medtronic Recalls StealthStation Due to Software Glitch

Medtronic’s September 27 recall of its StealthStation S8 Application Version 2.0 and 2.0.1 has been deemed Class I by the U.S. Food and Drug Administration (FDA).
 
StealthStation keeps track of the location of surgical tools during stereotactic surgery by using patient images. The system displays where the tool is on those images and models where the surgeon chose. That way, the surgeon can pre-operatively plan the path for tools and see how they should move.
 
These tools also help find body parts during brain surgery, both open or less invasive.
 
The company recalled StealthStation because of a software glitch that can cause surgical plan data to shift location(s) after the initial test is changed. This can cause the plan data to be in an unintended location for the procedure.
 
Medtronic reported to the FDA that there have not been injuries or deaths related to the software glitch. The FDA also advised that this recall is a correction, not a removal of products.
 
Medtronic’s Urgent Medical Device Correction Letter requested users not to change reference exams in cranial or ear, nose, and throat (ENT) procedures if surgical planning data is defined on a reference exam merged with pre-merge type or diffusion series. It also explained that users have to manually update existing plans to the original locations, or make new plans.