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U.S. Department of Health and Human Services

Class 2 Device Recall Synaptive Medical BrightMatter Navigator System

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 Class 2 Device Recall Synaptive Medical BrightMatter Navigator Systemsee related information
Date Initiated by FirmDecember 04, 2015
Date PostedDecember 23, 2015
Recall Status1 Terminated 3 on March 04, 2016
Recall NumberZ-0480-2016
Recall Event ID 72747
510(K)NumberK142024 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductSynaptive 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.
Code Information 00260001  00260002 00260006 00260007 00260005 00260003 00260004 00260012 
Recalling Firm/
Manufacturer		 Synaptive Medical, Inc.
101 College Street, Suite 200
MaRS Centre, South Tower
Toronto Canada
For Additional Information ContactThas Yuwaraj, PhD, PEng
844-462-7246
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionConsignees 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.
Quantity in Commerce8
DistributionUS: FL, WI, IL, LA, WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HAW
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