StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.
- Product
- StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
- Category
- Medical Device
- Distribution
- Distributed nationwide