Events

Recall of Device Recall Synaptive Medical BrightMatter Navigator System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synaptive Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72747
  • Event Risk Class
    Class 2
  • Event Number
    Z-0480-2016
  • Event Initiated Date
    2015-12-04
  • Event Date Posted
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142094
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Neurological stereotaxic Instrument - Product Code HAW
  • 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.
  • 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.

Device

Device Recall Synaptive Medical BrightMatter Navigator System
  • Model / Serial
    00260001  00260002 00260006 00260007 00260005 00260003 00260004 00260012
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: FL, WI, IL, LA, WA.
  • 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.
  • Manufacturer
    Synaptive Medical, Inc.

Manufacturer

Synaptive Medical, Inc.
  • Manufacturer Address
    Synaptive Medical, Inc., 101 College Street, Suite 200, MaRS Centre, South Tower, Toronto Canada
  • Manufacturer Parent Company (2017)
    Synaptive Medical, Inc.
  • Source
    USFDA