The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Publicado el 20 de junio de 2012 · Inicio del retiro: 7 de mayo 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
Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest sc
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Philips Medical Systems (Cleveland) Inc
- Distribuidor
- Worldwide Distribution - USA including AL, CA, DC, DE, FL, GA, IA, IN, MA, MD, MN, MS, NC, NY, OH, OR, PA, TN, TX, VT, WA & WV and the countries of Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, EGYPT, France, Germany, Greece, Hungary, ICELAND, India, Indonesia, Israel, ISRAEL, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, PHILIPPINES, POLAND, Portugal, Qatar, Russia, SINGAPORE, South Korea, SPAIN, SWEDEN, Switzerland, Taiwan, THAILAND, Turkey, UNITED KINGDOM & Uzbekistan.
- Lote
- Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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