Device Recall Ingenuity Core

Model #: 728321; Serial #s: 52000, 52001, 52002, 52004, 52006, 52007, 52008, 52009, 52010, 52013, 52015, 52016, 52017, 52018, 52020, 52021, 52022, 52024, 52026, 52033, 52038, 52039, 52046, 52051, 52052, 52057, 310001, 310002, 310003, 310004, 310005, 310006, 310007, 310009, 310010, 310011, 310012, 310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310081, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 310097, 310099, 310100, 310101, 310102, 310103, 310104, 310105, 310106, 310107, 310108, 310109, 310110, 310111, 310112, 310113, 310114, 310115, 310116, 310117, 310118, 310119, 310120, 310121, 310123, 310124, 310125, 310126, 310128, 310129, 310131, 310132, 310133, 310134, 310135, 310136, 310137, 310138, 310139, 310140, 310141, 310143, 310144, 310145, 310148, 310149, 310151, 310152, 310153, 310154, 310155, 310157, 310158, 310160, 310161, 310162, 310163, 310164, 310165, 310170, 310171, 333001, 333002, 333003, 333005, 333006, 333007, 333008, 333009, 333010, 333011, 333012, 333013, 333014, 333015, 333016, 333017, 333022, 333024, 333025, 333026, 333027, 333030, 333031, 333035, 333037, 333038, 333042, 333044, 333045, 333046, 333051, 333052, 333053, 333055, 333057, 333060, 333061, 333066.

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

Model #: 728323; Serial #s: 30153, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32010, 32011, 32013, 32014, 32015, 32016, 32018, 32021, 32023, 32025, 32026, 32029, 32030, 32031, 32032, 32033, 32034, 32035, 32036, 32037, 32038, 32040, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32051, 32052, 32053, 32054, 32057, 32059, 32060, 32062, 32064, 32066, 32068, 32069, 32070, 32072, 32073, 32074, 32077, 32078, 32080, 32083, 32084, 32089, 32091, 32092, 32094, 32095, 32098, 32100, 32101, 32104, 32106, 32107, 32108, 300137, 310067, 320001, 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320030, 320031, 320032, 320033, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320073, 320074, 320075, 320076, 320077, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105, 320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 320123, 320124, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320135, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144, 320145, 320146, 320147, 320148, 320150, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336011, 336012, 336013, 336014, 336015, 336016, 336018, 336020, 336021, 336024, 336027, 336028, 336029, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336044, 336046, 336047, 336048, 336050, 336052, 336055, 336056, 336057, 336058, 336059, 336061, 336063, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336074, 336075, 336076, 336080, 336081, 336086, 336087, 336089, 336702, 336703, 336704, 336705, 336706, 336708, 336709, 336710, 336711, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336721, 336707

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 Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Model #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310044, 310045, 310057, 310061, 310065, 310072, 310074, 310076, 310077, 310078, 310094, 310099, 310100, 310103, 310105, 310117, 310120, 310135.

Radiology Devices

2

No

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Model #: 728323; Serial #s: 310067, 320002, 320004, 320053, 320056.

Radiology Devices

2

No

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, 921223

Radiology Devices

2

No

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

Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.