FDAFDA · Alimentos y medicamentos·N.º oficial Z-2207-2012
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.
Publicado el 22 de agosto de 2012 · Inicio del retiro: 25 de julio de 2012
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
Essenta DR C-Arm may fall
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Healthcare Inc.
- Distribuidor
- Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
- Lote
- Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States