FDAFDA · Food and drugs·Recall number Z-2315-2016
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Published August 10, 2016 · Recall initiated: July 18, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Navigation, Inc.
- Distributor
- Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.
- Lot
- Model Number 9733986 . All lot numbers manufactured by Medtronic Navigation are affected.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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