Z-0480-2016Class II

Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is...

Name: Z-0480-2016 Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is...
Creator: Synaptive Medical, Inc.
Published: 2015-12-04
License: https://open.fda.gov/license/

Synaptive Medical Inc / initiated 2015-12-04 / Terminated / root cause: design

FDA source

Synaptive Medical, Inc. began a recall of 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... on 2015-12-04. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0480-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-04
Posted: 2015-12-23
Terminated: 2016-03-04
Recalling firm: Synaptive Medical Inc
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.
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were sent via courier on 12/4/2015 a Synaptive "Urgent Medical Device Recall" letter dated 30 November 2015. The letter described the problem and the device involved in the recall. Informed consignees that a technical support team member from Synaptive Medical will conduct the field correction. They also requested consignees to complete and return the Recall Response Form. For questions contact Thas Yuwaraj, PhD, .PEng Monday through Friday, 9 AM to 5 PM, Eastern Time at 1-844-462-7246.
Quantity in commerce: 8
Distribution: US: FL, WI, IL, LA, WA.
Product codes and lots: 00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0480-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0480-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

Product code HAW

K142024Class IIBrightmatter Navigation SystemSynaptive Medical, Inc. / cleared 2015-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)