Stealth S8 neurosurgical navigation software display error affecting surgical guidance
Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.
- Product
- Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
- Category
- Medical Device
- Distribution
- Distributed nationwide