FDAFDA · Alimentos y medicamentos·N.º oficial Z-1126-2013
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
Publicado el 24 de abril de 2013 · Inicio del retiro: 19 de marzo de 2013
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
A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Accuray Incorporated
- Distribuidor
- Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.
- Lote
- All units of these models.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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