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Medical Devices / Regulatory Affairs

Synaptive Recalls BrightMatter Guide Due to Software Defect

Nov. 30, 2018
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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.

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