Ingenuity Core 128

Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019, 32020, 32022, 32023, 32024, 32025, 32027, 32028, 32029, 32030, 32031, 32035, 32038, 32039, 32040, 32041, 32046, 32048, 32052, 32053, 32058, 32059, 32060, 32065, 32066, 320124, 320128, 320135, 320136, 320137, 320139, 320140, 320141, 320142, 320143, 320145, 320148, 320149, 320150, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336045, 336047, 336048, 336049, 336050, 336051, 336052, 336053, 336055, 336056, 336057, 336058, 336063, 336065, 336069, 336074, 336701, 336702, 336703, 336704, 336705, 336706, 336707, 336708, 336709, 336710, 336711, 336712, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336720, 336721, 336722, 336723, 336724, 336725, 336726, 336727, 336728, 336729, 336730, 336731, 336732, 336733, 336734, 336735, 336736 & 336737.

Radiology Devices

2

No

Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Model No. 728323; S/N: 30016, 32012, 32013, 32016, 32024, 32028, 32033, 32036, 32041, 32046, 32048, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32058, 32059, 32062, 32063, 32064, 32068, 32069, 32070, 32072, 32073, 32074, 32075, 32077, 32078, 32079, 32081, 32082, 32083, 32084, 32086, 32087, 32089, 32092, 32093, 32095, 32097, 32098, 32099, 32100, 32102, 32103, 32104, 32105, 32106, 32108, 32110, 32113, 32114, 32115, 32116, 32119, 32120, 32122, 32123, 32124, 32125, 32128, 32129, 32131, 32132, 32133, 32134, 32135, 32136, 32137, 32138, 32140, 32141, 32145, 32146, 320003, 320006, 320018, 320024, 320029, 320030, 320033, 320037, 320054, 320058, 320069, 320073, 320078, 320079, 320090, 320092, 320099, 320114, 320115, 320123, 320125, 320126, 320128, 320133, 320134, 320138, 320146, 320200, 320201, 320202, 320203, 320204, 320205, 320208, 320212, 320217, 320219, 320220, 320222, 320223, 320224, 320225, 320226, 320228, 320231, 320232, 320239, 320241, 320243, 320246, 320247, 336013, 336015, 336016, 336018, 336027, 336029, 336034, 336046, 336059, 336060, 336064, 336066, 336068, 336071, 336072, 336073, 336075, 336078, 336079, 336080, 336081, 336083, 336084, 336085, 336086, 336087, 336088, 336089, 336091, 336092, 336095, 336097, 336098, 336099, 336105, 336107, 336108, 336110, 336111, 336112, 336113, 336115, 336116, 336117, 336119, 336120, 336121, 336122, 336123, 336126, 336128, 336131, 336132, 336133, 336135, 336137, 336138, 336139, 336140, 336143, 336144, 336145, 336147, 336148, 336150 & 336151.

Radiology Devices

2

No

Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

Ingenuity Core 128 Computed Tomography X-ray system

32012, 32057, 320202, 320207, 320227, 320232, 336011, 336034, 336076, 336100, 336129, 336133, 336142, 36145, 336163

Radiology Devices

2

No

Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104. There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5. There were zero (0) Mexican accounts for this recall. The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

Ingenuity Core 128 Computed Tomography X-ray system, Model 728323

Brilliance CT 64, Ingenuity Core, Ingenuity Core 128 systems using software versions 2.6.1 or 3.5.4 (Computed tomography full-body x-ray system)ARTG Number: 98868