FDA-Device2017-07-26Class II
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Medtronic Navigation, Inc.
Hazard
Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with the StealthAiR Spine Frame during spine surgical procedures.
Sold states
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain.
Affected count
108
Manufactured in
826 Coal Creek Cir, N/A, Louisville, CO, United States
Products
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2746-2017Don't want to check this manually?
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