Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. Recalled by Synaptive Medical, Inc. Due to Out of tolerance for radio frequency emissions. At...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synaptive Medical, Inc. directly.
Affected Products
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
Quantity: 8
Why Was This Recalled?
Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.
Where Was This Sold?
This product was distributed to 5 states: FL, IL, LA, WA, WI
About Synaptive Medical, Inc.
Synaptive Medical, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report