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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0693-2017

Brilliance 64 728231 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

Publicado el 14 de diciembre de 2016 · Inicio del retiro: 12 de noviembre 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

Software error due to the filament on timer

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips Medical Systems (Cleveland) Inc
Distribuidor
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
Lote
4001, 4016, 9056, 9071, 9074, 9099, 9112, 9134, 9194, 9251, 9280, 9367, 9515, 9529, 9538, 9541, 9548, 9549, 9554, 9559, 9561, 9573, 9574, 9600, 9607, 9614, 9618, 9625, 9631, 9638, 9640, 9646, 9653, 9656, 9659, 9667, 9670, 9678, 9686, 9688, 9689, 9703, 9707, 9711, 9720, 9738, 9740, 9755, 9763, 9781, 9782, 9802, 9805, 9811, 9822, 9833, 9837, 9838, 9859, 9862, 9864, 9876, 9890, 9898, 9901, 9909, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9996, 9997, 10012, 10014, 10021, 10024, 10032, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10179, 10180, 10193, 10206, 10206, 10207, 10208, 10213, 10216, 10221, 10250, 10255, 10299, 10302, 10307, 10379, 10394, 10422, 10446, 10470, 10473, 10503, 10514, 10540, 10605, 10610, 10671, 10698, 10743, 29002, 29005, 29014, 29049, 29056, 29057, 29107, 29115, 90098, 90106, 90124, 90131, 90154, 90205, 90224, 91003, 95022, 95024, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95239, 95244, 95258, 95261, 95341, 95343, 95345, 95351, 95364, 95374, 95387, 95399, 95409, 95410, 95439, 95441, 95475, 95496, 95504, 95507, 95512, 95524, 95526, 95538, 95542, 95551, 95563, 95614, 95616, 95656, 95668, 95688, 95691, 95707, 95811, 6003368, 95341A
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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