Safety Alerts

Medical device manufacturer, Medtronic Navigation Inc, has issued a medical device safety alert concerning its StealthStation S8 and StealthStation FlexENT systems [Model Number: 9735762; Version 2.0 and 2.0.1] [HKMD No.: 210371].

The manufacturer has identified a software anomaly in StealthStation S8 Software App versions 2.0 and 2.0.1 that can occur within a Cranial (including DBS and Stereotaxy) or ENT procedure type, while merging exams with StealthMerge or StealthMerge ENT software, under the following specific clinical workflow scenarios:

• The navigation reference exam is merged with either a diffusion series (for tractography processing) or a pre-merge type series (an exam that does not contain anatomical information that must already be aligned or pre-merged to the anatomy in the reference exam - examples are a functional MRI activation map overlay or a PET exam).
• Surgical planning data (surgical plans, annotations, or AC-PC data) are defined on the reference exam merged with Pre-Merge type or Diffusion exams.
• The reference exam is changed to a different exam at a later point after initial planning is completed.

According to the manufacturer, if all three of the scenarios above occur, the surgical planning data may shift to an unintended location.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 29 Sep 2023