FDAFDA · Alimentos y medicamentos·N.º oficial Z-1204-2019
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control Console from software version 9.2.400 and higher; and Control Console from software version 11.0.400 and higher.
Publicado el 1 de mayo de 2019 · Inicio del retiro: 20 de marzo de 2019
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
Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc
- Distribuidor
- Nationwide
- Lote
- SIEMENS Digital Linear Accelerators of type ARTISTE", ONCOR" and PRIMUS" running: - Control Console from software version 13.0.302 and higher - Control Console from software version 9.2.400 and higher - Controle Console from software version 11.0.400 and higher
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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