Synaptive Recalls BrightMatter Guide Due to Software Defect
November 29, 2018
Synaptive Medical issued a Class I recall of certain BrightMatter Guide with SurfaceTrace Registration devices over a software defect that could potentially create serious risks during brain surgery.
The system provides surgeons with detailed 3D images of a patient’s brain to help them navigate surgical tools during brain surgery.
The software defect may be triggered when the system is used with a specific third-party port — the NICO BrainPath Device — and prevents the surgeon from being able to accurately see the location of surgical tools in the patient’s brain.