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Medtronic Navigation, Inc. recalls Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Recalled July 26, 2017 · FDA recall Z-2746-2017 · Medtronic Navigation
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. · FDA Class II
Units
108
Sold at
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain.
Description
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.
Product
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →