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

FDA Recall #Z-0480-2016 — Class II — December 4, 2015

Recall #Z-0480-2016 Date: December 4, 2015 Classification: Class II Status: Terminated

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.

Recalling Firm

Synaptive Medical, Inc. — Toronto, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

8

Distribution

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

Code Information

00260001 00260002 00260006 00260007 00260005 00260003 00260004 00260012

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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