Device Recall Ingenuity CT

Model #: 728326; Serial #s: 30003, 30005, 30006, 30007, 30008, 30009, 30011, 30012, 30013, 30014, 30015, 30018, 30019, 30022, 30028, 300003, 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020, 300021, 300024, 300025, 300027, 300028, 300029, 300031, 300032, 300033, 300034, 300035, 300036, 300037, 300038, 300039, 300040, 300041, 300042, 300043, 300044, 300045, 300046, 300047, 300048, 300049, 300050, 300051, 300052, 300053, 300054, 300055, 300056, 300057, 300058, 300059, 300060, 300061, 300062, 300063, 300065, 300066, 300068, 300069, 300070, 300071, 300072, 300073, 300074, 300075, 300077, 300078, 300079, 300080, 300081, 300082, 300084, 300085, 300086, 300087, 300088, 300089, 300090, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300116, 300117, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131, 300132, 300135, 300136, 300139, 300140, 300142, 300143, 300144, 300145, 300147, 300148, 300149, 300150, 300151, 300156, 300157, 300158, 300159, 300160, 300161, 300162, 300163, 300164, 300165, 300166, 310058 & 30004-1.

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.

Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Model #728326, Serial Numbers: 300003, 300004, and 300005.

Radiology Devices

2

No

Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. || Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

The following Serial Numbers of this device are subject to recall: Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) in the states of: LA, NY, OH, WV and the foreign countries of: Australia, Germany, Korea, India, Malaysiaa and New Zealand.

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. || Product Usage: || The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

The following Serial Numbers are subject to recall/software correction: 300003, 300004, 300005, and 300010.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: IN and OR; and countries of: Australia and Germany.

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. || Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-a¿sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.