Use cautionMedical device recall · FDA · Published October 9, 2018
Synaptive BrightMatter Guide Software Defect Risk in Surgery
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.
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Contact the company
📍Recalling firmSynaptive Medical Inc555 Richmond St West, Suite 800 · Toronto, Canada
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/69656-synaptive-brightmatter-guide-software-defect-risk-in-surgery.
“Synaptive BrightMatter Guide Software Defect Risk in Surgery.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69656-synaptive-brightmatter-guide-software-defect-risk-in-surgery. Based on FDA recall #Z-0470-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0470-2019%22&limit=1).
The FDA announced on Oct. 9, 2018, that Synaptive Medical Inc is recalling BrightMatter Guide software versions 1.5.0, 1.5.1 and 1.5.2 due to a defect that may trigger errors during surgical procedures. The agency classified the recall as Class I.
The recall addresses a software defect in the Guide System software when used with NICO BrainPath ports. The defect is triggered when a user switches between trajectories set with a blue port and another set with a gold port during a surgical procedure.
Context
GovInfoNow's records show Synaptive Medical Inc has two other recalls on record since Feb. 26, 2020. On April 23, 2021, the company recalled Trackable Suction Sets due to metal filings risk. On Feb. 26, 2020, Synaptive ClearCanvas RIS/PACS Software was recalled for a defect that may cause misdiagnosis. Other recent recalls of similar products include Alphatec SafeOp Patient Interface Software Issue May Cause System Faults (May 13, 2026), Da Vinci 5 Surgical System Software Error May Cause Monitor Content Loss (Nov. 17, 2025) and Medtronic Restore CP App Model A71100 Software Issue: Rare Therapy Disruption Risk (Nov. 20, 2025).
How to tell if you have this one
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.
Brand
Synaptive Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your BrightMatter Guide software version by checking the device settings or documentation.
Update Software
Update to a newer software version if available through the manufacturer's support channels.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide Distribution and the country of Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0470-2019 (October 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0470-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.