FDAFDA · Alimentos y medicamentos·N.º oficial Z-0161-2018
ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Publicado el 29 de noviembre de 2017 · Inicio del retiro: 4 de junio de 2014
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
Software corrections reactivating the cooperative endoscopy mode.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- Zimmer Biomet, Inc.
- Distribuidor
- Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.
- Lote
- Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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