FDAFDA · Alimentos y medicamentos·N.º oficial Z-1003-2013
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
Publicado el 24 de abril de 2013 · Inicio del retiro: 5 de abril de 2010
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
Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Healthcare Inc.
- Distribuidor
- Worldwide Distribution including USA (nationwide)
- Lote
- Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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