Synaptive Medical, Inc. recalls Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of…

Recall date

December 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0480-2016

FDA classification

Class II

Brand / firm

Synaptive Medical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.