Stealthstation System Update

• • Terminated Z-2746-2017 FDA Class II ·initiated 10 May 2017

  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.

• 2 recalls, same reason

  • Terminated Z-2318-2016 FDA Class II ·initiated 18 Jul 2016
  • Terminated Z-2313-2016 FDA Class II ·initiated 18 Jul 2016

  Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

• • Terminated Z-2824-2015 FDA Class II ·initiated 14 Sep 2015

  Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.

• • Terminated Z-0441-2013 FDA Class II ·initiated 13 Nov 2012

  Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.

• • Terminated Z-2781-2011 FDA Unclassified (pre-2012) ·initiated 2 Jun 2011

  Software allows incorrect patient or patient history to be displayed.

• • Terminated Z-1558-2011 FDA Unclassified (pre-2012) ·initiated 22 Dec 2010

  Position Sensor Unit may generate tracking errors or may stop tracking immediately.

• • Terminated Z-1042-2011 FDA Unclassified (pre-2012) ·initiated 15 Dec 2010

  Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.

• • Terminated Z-0715-2011 FDA Unclassified (pre-2012) ·initiated 5 Nov 2010

  Electronic surgical navigation aid may lose tracking ability or stop working.

• • Terminated Z-0145-2011 FDA Unclassified (pre-2012) ·initiated 24 Sep 2010

  Drill guide handle may detach unintentionally during use.

• • Terminated Z-2029-2010 FDA Unclassified (pre-2012) ·initiated 14 Jun 2010

  Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock.

510(k) Number

K050438 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Hip Module for the Stealthstation System

  Class II

  FDA 510(k) K021980 Active Cleared 19 Nov 2002

• Medtronic Snt Stealthstation Axiem Imageless Knee Module

  Class II

  FDA 510(k) K043088 Active Cleared 5 Jan 2005

• Stealthstation with Fluoromerge Software

  Class II

  FDA 510(k) K020338 Active Cleared 27 Feb 2002

• Imageless Knee Module for the Stealthstation System

  Class II

  FDA 510(k) K030552 Active Cleared 19 Mar 2003

• Stealthstation System Goldeneye Micro-Magnetic Tracking System

  Class II

  FDA 510(k) K001284 Active Cleared 12 Jun 2000

• Stealthstation System Three Dimensional C-Arm Interface

  Class II

  FDA 510(k) K022414 Active Cleared 14 Aug 2002

See all devices from Medtronic Surgical Navigation Technologies →