Synaptive Medical BrightMatter Navigator System — Class II medical device recall Z-0480-2016
Terminated recall by Synaptive Medical, Inc., reported 2015-12-30, distributed in FL, IL, LA, WA, WI. Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the Bright
| Recall number | Z-0480-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synaptive Medical, Inc., Toronto, N/A, Canada |
| Recall initiated | 2015-12-04 |
| Classified | 2015-12-23 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-03-04 |
| Distributed | FL, IL, LA, WA, WI |
| Quantity | 8 |
| Model numbers | SYN-0026 |
Product
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.