• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    LifeQ Unveils New 24-Hour Sleep Solution

    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll

    EvoEndo Names CEO and Chief Operating Officer

    Electromedical Products International Forms Scientific Advisory Board

    Sonendo Bolsters its Operational Executive Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Halkey-Roberts Corporation

    LEMO USA Inc.

    Fusion Biotec Inc.

    JBC Technologies

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    LEMO USA Inc.

    Fusion Biotec Inc.

    JBC Technologies

    Medbio LLC
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Medtronic Recalls Cranial Software Over Inaccuracies Displayed During Surgical Procedures

    Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System are being recalled.

    U.S. Food and Drug Administration01.09.19
    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
     
    • Recalled Product(s): Synergy Cranial Software and Stealth Station S7 Cranial Software
    • Model Numbers: 9733763 with software versions 2.2.0, 2.2.5, 2.2.6, 2.2.7; 9735585 with software versions 3.0.0, 3.0.1, 3.0.2, 3.1.0
    • Manufacturing Dates: August 31, 2011, to October 16, 2018
    • Distribution Dates: August 31, 2011, to October 16, 2018
    • Devices Recalled in the U.S.: 5487
     
    The Synergy Cranial Software and StealthStation S7 Cranial Software, used with the StealthStation Surgical Navigation System, provides detailed three-dimensional (3D) images of a patient's brain to help neurosurgeons safely navigate surgical tools and implants used during brain surgery.
     
    Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm.

    During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.
     
    Neurosurgeons and other trained medical personnel using the Synergy Cranial Software and StealthStation S7 Cranial Software to perform neurosurgical procedures and patients undergoing a neurosurgical procedure using the Synergy Cranial Software and StealthStation S7 Cranial Software to perform neurosurgical procedures are affected.
     
    What to Do
    On September 21, 2018, Medtronic sent an Urgent Medical Device Correction notice to customers. The notice provided the following mitigation to eliminate the risk of damaging healthy tissue:
     
    • Do not set a projection longer than the length of the surgical plan.
    • Follow the Cranial Software Pocket Guide, and always use the Biopsy Needle Mechanical Depth Stop.
    • Ensure the Navigate Instrument Tip setting is selected prior to locking the trajectory and navigating the instrument.
     
    The notice also instructed customers to take the following actions:

    • Review the notice and ensure appropriate staff are aware of the issue.
    • Sign and date the Consignee Response Form attached to the notice, and return the form to Medtronic by email at RS.NavFCA@Medtronic.com or fax to Medtronic Technical Services at 651-367-7075 within 30 days of receipt.
     
    On December 28, 2018, Medtronic reported they were continuing to follow up with customers about their Urgent Medical Device Correction over the next months.
    Related Searches
    • implants
    • Software
    • mechanical
    • medtronic
    Related Knowledge Center
    • Neurological
    • Surgical
    Suggested For You
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    RapidPulse Closes $15 Million Series A Financing RapidPulse Closes $15 Million Series A Financing
    Luis J. Malavé Joins Integrity Applications Board Luis J. Malavé Joins Integrity Applications Board
    Bright Future Ahead for Renal Denervation Bright Future Ahead for Renal Denervation
    iCAD Signs Global Distribution Agreement With Sectra iCAD Signs Global Distribution Agreement With Sectra
    Cala Health Expands its Executive Team Cala Health Expands its Executive Team
    Outset Medical Appoints Katie Szyman to its Board Outset Medical Appoints Katie Szyman to its Board
    Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027 Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027
    Substantial Growth Predicted for Global Ventilators Market Substantial Growth Predicted for Global Ventilators Market
    Fluid Management System Market to be Worth $23.2 Billion By 2028 Fluid Management System Market to be Worth $23.2 Billion By 2028
    Receiving FDA Approval in Under One Month Receiving FDA Approval in Under One Month
    The Future of AI and OR Medical Devices The Future of AI and OR Medical Devices
    The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology
    Medtronic Starts Construction on New Innovation Center Medtronic Starts Construction on New Innovation Center
    Expanded FDA Approval for Medtronic Expanded FDA Approval for Medtronic's Arctic Front Cryoablation Catheter

    Related Breaking News

    • Medical Devices Market to Top $671.49 Billion by 2027

      Medical Devices Market to Top $671.49 Billion by 2027

      Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.
      Precedence Research 09.16.21

    • RapidPulse Closes $15 Million Series A Financing

      RapidPulse Closes $15 Million Series A Financing

      Two industry veterans join the team to support the development of a cyclic aspiration system for ischemic stroke.
      Globe Newswire 09.10.21

    • Luis J. Malavé Joins Integrity Applications Board

      Luis J. Malavé Joins Integrity Applications Board

      New member has more than 30 years of leadership experience in the medtech industry, primarily in diabetes management.
      Globe Newswire 09.08.21


    • Bright Future Ahead for Renal Denervation

      Bright Future Ahead for Renal Denervation

      No devices yet approved in the United States for the high blood pressure treatment.
      GlobalData 09.02.21

    • Digital Health
      iCAD Signs Global Distribution Agreement With Sectra

      iCAD Signs Global Distribution Agreement With Sectra

      Agreement will expand access to ProFound AI and ProFound AI Risk to more facilities and imaging centers worldwide.
      Globe Newswire 08.19.21

    Loading, Please Wait..

    Trending
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • FDA Clears Sanara MedTech's Advanced Surgical Solution
    • Titan Medical Licenses Most IP To Intuitive; CEO Steps Down
    Breaking News
    • LifeQ Unveils New 24-Hour Sleep Solution
    • Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    • EvoEndo Names CEO and Chief Operating Officer
    • Electromedical Products International Forms Scientific Advisory Board
    • Sonendo Bolsters its Operational Executive Team
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Teal and Mackrill Director Geoff Mackrill Honored by BCF
    Evonik's TEGO Airex 923 Wins 2023 Ringier Technology Innovation Award
    120 Years HOFFMANN MINERAL - Success Through Innovation and Responsibility
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    LifeQ Unveils New 24-Hour Sleep Solution
    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    EvoEndo Names CEO and Chief Operating Officer
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Dragonfly Therapeutics Expands Clinical Leadership Team
    Innovent Enters into Clinical Trial Collaboration with Merck KGaA
    Aerami Therapeutics Expands Management Team
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    Uoma Beauty Founder and CEO Sharon Chuter Steps Down
    Peter Thomas Roth Rolls Out Ultimate Solution 5 Multitasking Moisturizer
    Colorproof Teams Up with the It Gets Better Project on Limited-Edition Hair Care Kits
    Ink World

    Latest Breaking News From Ink World

    WestRock Advances its Commitment to a Sustainable Future
    Roland DGA Announces Key Service Department Personnel Changes
    The 2023 CPIPC Golf Outing is Teeing Off on June 21
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Appvion announces new, sustainable coatings for label facestocks
    Epson teams with 5 Gyres Institute to battle plastic pollution
    Maxcess opens new facility in India
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Orthofix Unveils Seven-Year Outcome Data for M6-C Artificial Cervical Disc
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia
    Vitesco Technologies, onsemi Sign SiC Long-Term Supply Agreement

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login