FDAFDA · Alimentos y medicamentos·N.º oficial Z-0077-2017
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Publicado el 19 de octubre de 2016 · Inicio del retiro: 13 de septiembre 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
Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Varian Medical Systems, Inc.
- Distribuidor
- US Distribution and Internationally to 1 site in Canada, India and Morocco
- Lote
- All Head Frame Posts and Post kits
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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