Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0470-2019 — 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

U.S. FDA — Device Enforcement · Canada · 2018-10-09 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0470-2019
Date of alert: 2018-10-09
Country / jurisdiction: Canada
Risk level: Class I
Risk type: recall
Brand: Synaptive Medical Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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