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U.S. Department of Health and Human Services

Class 1 Device Recall BrightMatter Guide

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  Class 1 Device Recall BrightMatter Guide see related information
Date Initiated by Firm October 09, 2018
Date Posted November 26, 2018
Recall Status1 Terminated 3 on August 12, 2021
Recall Number Z-0470-2019
Recall Event ID 81317
510(K)Number K153281  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2

Product Usage:
BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.
Code Information Serial Numbers: 0063HJ5Y062  00635F48562  00635GTYK32  00638HTZK32  0063G6DRM12  0063CPBRM12  006395Q2Z52  0063J9BD062  00634X19562  0063GN0B562  00637BP9562  0063JTDW462  00638J89562  006360JV462  0063F1Q2Z52  0063FGWYK32  006384WYK32  00635YH8562  0063C2SKH72  00635NWPK12  0063DKWYK32  006358Q2Z52  0063HM0B562  0063DZPGP12  00634BBD062  00636L48562  0063DD8GP12  0063HCZ1Z52  006318XYK32  0003CZDRLC2  0063GLD6562  0063HRZYK32  006317B8562  006348M5562  0063HGTYK32  0063FHXY062  00634DBD062  
Recalling Firm/
Manufacturer		 Synaptive Medical Inc
555 Richmond St West, Suite 800
Toronto Canada
For Additional Information Contact Thas Yuwaraj, PhD, PEng
647-243-3123
Manufacturer Reason
for Recall		 This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.
FDA Determined
Cause 2		 Software design
Action Synaptive Medical sent an Urgent Medical Device Recall letter dated October 9, 2018 via registered priority mail. The letter identified the affected product, problem and actions to be taken until a software patch is released. Customers were requested to complete and return the enclosed Acknowledgement and Receipt form to Synaptive Medical Inc. For questions call 1-844-462-7246.
Quantity in Commerce 37 units
Distribution Worldwide - US Nationwide Distribution and the country of Canada
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HAW and Original Applicant = SYNAPTIVE MEDICAL INC.
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