Device Recall Brilliance CT Big Bore

System Code #, 728243, Serial #, 7039

Radiology Devices

2

No

Distributed in China.

Brilliance CT Big Bore Oncology. || 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.

Model #: 728244; Serial #s: 7486, 7510, 7514, 7525, 7529, 7533, 7538, 7543, 7544, 7546, 7557, 7570, 7571, 7572, 7575, 7576, 7583, 7586, 7587, 7594, 7595, 7600, 7604, 7607, 7610, 7614, 7619, 7621, 7625, 7631, 7632, 7636, 7651, 7653, 7654, 7660, 7668, 7669, 7670, 7676, 7683, 7686, 7688, 7692, 7694, 7697, 7708, 7710, 7711, 7712, 7713, 7714, 7717, 7719, 7721, 7722, 7723, 7732, 7733, 7734, 7738, 7742, 7746, 7747, 7756, 7760, 7764, 7766, 7767, 7771, 7772, 7773, 7778, 7780, 7781, 7789, 7790, 7798, 7804, 7809, 7813, 7819, 7825, 7826, 7830, 7839, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7943, 7952, 7957, 7958, 7959, 7964, 7967, 7979, 7981, 7986, 7988 & 7992.

Radiology Devices

2

No

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

921216

Radiology Devices

2

No

Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

Model #: 728243; 7133, 7170, 7225, 7262, 7265, 7701, 7706, 7779, 7788, 7792, 7797, 7802, 7805, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7816, 7824, 7831, 7832, 7833, 7834 ,7835.  Model #728244; 7621, 7636, 7809 & 7844.

Radiology Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates.

Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. || Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.