Medtronic has issued a recall on their S8 software version 2.0 and 2.0.1. There are 2,109 units affected and a letter has been sent to all affected customers in late September, 2023.
Reason for recall
Medtronic Navigation Inc. is recalling StealthStation S8 Application Version 2.0 and 2.0.1 due to a software glitch that can make the surgical plan data shift location(s) after the initial test is changed. This can cause the surgical plan data to be in an unintended location for the surgery.
What to do
Not change the reference exam in Cranial or ENT procedures, if the surgical planning data is defined on a reference exam merged with pre-merge type or diffusion series. The incorrect surgical plan data cannot be recovered by reverting to the original reference exam. To resolve this issue, the user must manually update the existing plans to the original locations or make new plans.
Visit the FDA’s website for more information here.
