FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 10 de agosto de 2016 · Inicio del retiro: 18 de julio de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Navigation, Inc.
- Distribuidor
- 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.
- Lote
- Model Number 9733986 . All lot numbers manufactured by Medtronic Navigation are affected.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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