FDAFDA · Alimentos y medicamentos·N.º oficial Z-1505-2016
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Publicado el 27 de abril de 2016 · Inicio del retiro: 4 de marzo 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
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Medical Systems (Cleveland) Inc
- Distribuidor
- Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.
- Lote
- M/N 882488; S/N: 66565, 66586, 66589, 66670, 66681, 66672, 66644, 66888, 66374, 66371, 66305, 66824, 66261, 66356, 66059, 66056, 67027, 66248, 66590, 66240, 66097, 66268, 66555, 66500, 66754, 66469, 66411, 66252, 66263, 66307, 66311, 66310, 66306, 66259, 67054, 67000 & 67017.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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