FDAOctober 9, 2018device
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.
What to do
FDA enforcement status: Terminated
Brands named
synaptive medicalsynaptive
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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