Class II — Synaptive Medical, Inc.
| Recalling firm | Synaptive Medical Inc |
|---|---|
| Registered facility | Synaptive Medical Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 8 |
| Distribution | US: FL, WI, IL, LA, WA. |
| Initiated | 2015-12-04 |
| Classified | 2015-12-23 |
| Terminated | 2016-03-04 |
| Recall number | Z-0480-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Synaptive Medical, Inc. (Z-0480-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72747/
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