Synaptive Medical Recalls BrightMatter Guide Software Due to Defect
Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software due to a defect that occurs when switching between specific port trajectories during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric, despite the lack of reported injuries.
Plain-English summary
Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software, Product Number SYN-0026, versions 1.5.0, 1.5.1, and 1.5.2. The affected software is used to navigate third-party NICO BrainPath ports by attaching a custom Tracking Array. The recall covers units distributed in the United States and Canada.
The recall was initiated due to a software defect that is triggered under specific circumstances. The defect occurs when a user sets one trajectory with a blue port and another trajectory with a gold port, and then switches between these trajectories during a surgical procedure. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare providers and facilities that have received the affected software should stop using it and contact Synaptive Medical Inc for further instructions. The recall is classified as Class I by the FDA.
The recalled product
- Product
- 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 co
- Manufacturer
- Synaptive Medical Inc
- Hazard
- Affected units
- 37
Distribution
Distributed nationwide across the United States.
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