Synaptive Medical recalls BrightMatter Guide software versions 1.5.0-1.5.2 due to a defect that may cause errors during surgical procedures when switching between blue and gold NICO BrainPath ports.
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.
Synaptive Medical is recalling BrightMatter Guide software versions 1.5.0 through 1.5.2 because a software defect can cause errors during surgery when switching between blue and gold NICO BrainPath ports. This could lead to incorrect surgical navigation if the software malfunctions during the procedure.
The software defect occurs when switching between trajectories set with blue and gold NICO BrainPath ports during surgery. This can cause the system to display incorrect navigation information, potentially leading to errors in surgical procedures.
Surgical teams using BrightMatter Guide software versions 1.5.0 through 1.5.2 with NICO BrainPath ports. Surgeons and surgical technicians who work with these specific software versions are most at risk.
Check for serial numbers starting with 0063 or 0003 (e.g., 0063HJ5Y062, 00635F48562) on the BrightMatter Guide device. The affected software versions are 1.5.0, 1.5.1, and 1.5.2.
Verify your BrightMatter Guide software version by checking the device settings or documentation.
Update to a newer software version if available through the manufacturer's support channels.
The defect can cause errors when switching between blue and gold NICO BrainPath ports during surgery, potentially leading to incorrect navigation of surgical instruments.
Affected serial numbers start with 0063 or 0003 (e.g., 0063HJ5Y062, 00635F48562).
Contact Synaptive Medical directly for software updates or support information.
We’ve drafted a message you can send Synaptive Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0470-2019 — Synaptive Medical Synaptive Medical Hello, I own a Synaptive Medical that is covered by recall Z-0470-2019 from Synaptive Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
