Recall Z-0480-2016— Synaptive Medical, Inc.

Name: FDA recall Z-0480-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-04

Class II · Terminated

Class II FDA medical device recall by Synaptive Medical, Inc., initiated 2015-12-04, terminated 2016-03-04. It names one FDA 510(k) clearance: K142024. 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..

Recalling firm: Synaptive Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-04
Terminated: 2016-03-04
Firm location: Toronto, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K142024 — BRIGHTMATTER NAVIGATION SYSTEMSynaptive Medical, Inc.·cleared 2015-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.