Synaptive Medical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0480-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 4, 2015

Date Posted: December 30, 2015

Recall Number: Z-0480-2016

Event ID: 72747

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.

Status: Terminated

Product Quantity: 8

Code Information:

00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012

Distribution Pattern:

US: FL, WI, IL, LA, WA.

Voluntary or Mandated:

Voluntary: Firm initiated