FDA Device recall Z-0480-2016
Synaptive Medical BrightMatter Navigator System (Guide System)
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Synaptive Medical BrightMatter Navigator System (Guide System) by Synaptive Medical, citing 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 appl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0480-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-04 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synaptive Medical |
| Distribution | FL, IL, LA, WA, WI |
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
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.
Identifiers
| code_info | 00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0480-2016%22
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