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

Recall details

Manufacturer

Philips Medical Systems (Cleveland) Inc

Distributor

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.

Lot

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

Risk classification

Class II

Area (FDA)

device

Country

United States