The Recall Desk
ModerateFDA (Devices)·Z-0480-2016·Announced 2015-12-30

Synaptive Medical BrightMatter Navigator System Recalled for RF Emission Exceedance

Synaptive Medical is recalling eight BrightMatter Navigator Systems because they exceeded radio frequency emission limits. The devices were distributed to facilities in five US states.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a technical compliance issue (RF emissions) without reported adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Synaptive Medical, Inc. is recalling eight units of the BrightMatter Navigator System (Guide System), part number SYN-0026. This system is a planning and intraoperative guidance device used for open and percutaneous computer-assisted neurosurgical cranial procedures. The recall involves specific units identified by codes 00260001 through 00260012.

The recall was initiated because testing indicated that the systems were out of tolerance for radio frequency emissions. Specifically, at the 150-1000MHz frequency, the devices emitted up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification. The affected units were distributed to facilities in Florida, Wisconsin, Illinois, Louisiana, and Washington.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any injuries or illnesses associated with the emission exceedance.

The recalled product

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 a
Manufacturer
Synaptive Medical, Inc.
Category
Medical Device — Neurosurgical Guidance
Hazard
Affected units
8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012

Distribution

Distributed in 5 states:

Related recalls

Same manufacturer · Synaptive Medical, Inc.

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