Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Publicado el 6 de marzo de 2013 · Inicio del retiro: 24 de octubre 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
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Medical Systems (Cleveland) Inc
- Distribuidor
- Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..
- Lote
- The affected GEMINI Big Bore system is identified with the following Serial Numbers: 9004, 9005, 9006, 9008 ,9009, 9010, 9011, 9012, 9013, 9014, 9014, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9205, 9206, 9207, 9208, 9209, 9210, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, and 9221.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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