Device Recall Brilliance 64:Computed Tomography Xray Systems,

  • 모델명 / 제조번호(시리얼번호)
    Model No. 728231; S/N: 1, 2, 4001, 9056, 9074, 9099, 9134, 9251, 9515, 9529, 9538, 9549, 9554, 9573, 9574, 9618, 9625, 9638, 9646, 9653, 9656, 9659, 9667, 9670, 9686, 9689, 9690, 9703, 9738, 9740, 9755, 9782, 9811, 9822, 9833, 9837, 9838, 9859, 9862, 9898, 9901, 9909, 9910, 9917, 9920, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 10021, 10024, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10180, 10189, 10193, 10206, 10206, 10208, 10213, 10250, 10253, 10299, 10379, 10394, 10422, 10670, 10671, 10677, 10678, 10683, 10684, 10685, 10695, 10698, 10794, 10799, 10803, 29002, 29014, 29056, 29070, 29107, 29115, 90100, 90124, 90150, 90154, 91003, 95022, 95024, 95100, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95258, 95261, 95333, 95351, 95364, 95387, 95399, 95410, 95473, 95475, 95496, 95504, 95507, 95512, 95524, 95551, 95563, 95614, 95616, 95668, 95688, 95691, 95703, 95704, 95705, 95706, 95707, 95708, 95709, 95710, 95711, 95713, 95716, 95717, 95718, 95720, 95721, 95722, 95723, 95724, 95725, 95726, 95727, 95728, 95729, 95730, 95731, 95732, 95733, 95734, 95735, 95736, 95737, 95738, 95739, 95740, 95741, 95742, 95744, 95745, 95746, 95747, 95748, 95749, 95750, 95751, 95752, 95753, 95754, 95755, 95756, 95757, 95758, 95759, 95760, 95761, 95762, 95764, 95765, 95766, 95767, 95769, 95770, 95772, 95773, 95774, 95775, 95776, 95777, 95778, 95779, 95780, 95781, 95786, 95787, 95788, 95789, 95790, 95791, 95794, 95795, 95797, 95798, 95799, 95800, 95801, 95802, 95803, 95804, 95805, 95806, 95807, 95808, 95809, 95810, 95811, 95812, 95813, 95815, 95817, 95821, 95824, 95830, 95831, 95832, 95834, 95835, 95837, 95842, 95843, 95845, 95849, 95852, 95853, 95854, 95855, 95857, 95864, 95869, 95874, 95876, 95877, 95881, 95886, 95900, 95901, 95902, 95903, 95904, 95906, 95907, 95910, 95911, 95912, 95915, 95916, 95917, 95918, 95919, 95922, 95924, 95925, 95927, 95928, 95929, 95930, 95934, 95938, 95940, 95941, 95942, 95944, 95946, 95341A, 123002 & 123029.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • 제품 설명
    Brilliance 64: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
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model No. 728306; S/N: 85004, 85010, 85012, 85013, 85014, 85015, 85016, 85017, 85018, 85021, 85022, 85023, 85024, 85025, 85026, 85027, 85028, 85029, 85032, 85033, 85034, 85035, 85036, 85037, 85038, 85039, 85040, 85043, 85044, 85045, 85046, 85047, 85048, 85049, 85050, 85051, 85054, 85055, 85056, 85057, 85058, 85059, 85060, 85061, 85062, 85065, 85066, 85067, 85068, 85069, 85070, 100016, 100018, 100019, 100025, 100037, 100038, 100040, 100044, 100048, 100049, 100050, 100051, 100058, 100062, 100064, 100065, 100070, 100072, 100082, 100084, 100091, 100099, 100101, 100103, 100111, 100113, 100114, 100115, 100119, 100122, 100133, 100134, 100135, 100140, 100144, 100149, 100153, 100161, 100162, 100170, 100178, 100180, 100181, 100184, 100185, 100190, 100191, 100192, 100200, 100214, 100215, 100217, 100221, 100222, 100228, 100231, 100236, 100247, 100260, 100270, 100271, 100273, 100274, 100278, 100280, 100281, 100302, 100304, 100308, 100309, 100310, 100314, 100318, 100325, 100329, 100343, 100346, 100350, 100351, 100356, 100360, 100365, 100368, 100370, 100374, 100393, 100396, 100398, 100399, 100400, 100402, 100405, 100406,  100416, 100423, 100436, 100441, 100446, 100449, 100450, 100452, 100453, 100461, 100462, 100463, 100464, 100465, 100466, 100469, 100472, 100483, 100493, 100494, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100517, 100518, 100520, 100521, 100522, 100600, 100601, 100602, 100603, 100606, 100607, 100608, 100609, 100610, 100611, 100612, 100613, 100614, 100617, 100618, 100619, 100620, 100621, 100622, 100623, 100624, 100625, 100628, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100636, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100646, 100647, 100650, 100651, 100652, 100653, 100654, 100655, 100656, 100657, 100658, 100661, 100662, 100663, 100664, 100665, 100666, 100667, 100668, 100669, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100680, 100681,  100684, 100685, 100686, 100687, 100688, 100689, 100690, 100691, 100692, 100693, 100695, 100696, 100697, 100698, 100699, 100701, 100702, 100704, 100705, 100706, 100707, 100708, 200004, 200005 & 200098.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • 제품 설명
    Brilliance iCT 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
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model No. 728311; S/N: 200011, 200013, 200017, 200022, 200027, 200030, 200032, 200038, 200040, 200047, 200049, 200051, 200061, 200063, 200067, 200068, 200074, 200088, 200093, 200097, 200100, 200101, 200105, 200107, 200109, 200111, 200117, 200121, 200127, 200131, 200138, 200200, 200201, 200202, 200203, 200204, 200205, 200206, 200207, 200208, 200209, 200210 & 200211.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • 제품 설명
    Brilliance iCT SP 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
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model No. 728321; S/N: 31001, 52000, 52012, 52015, 52018, 52020, 52022, 52030, 52031, 52044, 52050, 52063, 310001, 310022, 310023, 310026, 310032, 310039, 310065, 310077, 310078, 310096, 310102, 310105, 310115, 310125, 310133, 310135, 310157, 310160, 310164, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310245, 310246, 310247, 310248, 310249, 310250, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310287, 310288, 310289, 310290, 310291, 310292, 333002, 333005, 333008, 333010, 333015, 333018, 333021, 333042, 333043, 333051, 333060, 333061, 333064, 333106, 333107, 333108, 333109, 333110, 333112, 333114, 333115, 333116, 333117, 333121, 52062, 52066, 52080, 52081 52082, 52083, 52084, 310286, 333004, 333111, 333113, 333118, 333119 & 333120.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • 제품 설명
    Ingenuity Core 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
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model No. 728323; S/N: 30016, 30023, 30151, 30153, 32000, 32001, 32008, 32012, 32042, 32044, 32057, 32061, 32065, 32067, 32068, 32069, 32076, 32100, 32106, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162,  32163, 32164, 32165, 32166, 32167, 52023, 52028, 52049, 320001, 320003, 320006, 320008, 320010, 320024, 320026, 320029, 320031, 320037, 320054, 320070, 320078 320090, 320092, 320107, 320202, 320207, 320224, 320225, 320226, 320227, 320228, 320229 320230, 320231, 320232, 320233, 320234, 320235, 320236, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 320247, 320248, 320250, 320251, 320252, 320254, 320255, 320256, 320258, 336011, 336012, 336015, 336016, 336018, 336025, 336027, 336028, 336029, 336034, 336040, 336044, 336068, 336072, 336076, 336092, 336100, 336102, 336104, 336142, 336148, 336149, 336150, 336151, 336152, 336153, 336154, 336155, 336156, 336157, 336158, 336159, 336160, 336161, 336162, 336163, 336164, 336166, 336167, 336168, 336170, 336171, 336172, 336173, 336174, 336175, 336176, 336177, 336178, 336180, 336181, 336182, 336183, 336184, 336185, 336186, 336188, 336190, 336192, 336193, 336194, 30035, 320257, 333047, 336165, 336179, 336187, 336189, 336191, 336195, 336196, 336197, 336199 & 336200.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • 제품 설명
    Ingenuity Core 128 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
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model No. 728326; S/N: 30003, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018, 30019, 30020, 30021, 30022, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 30044, 30045, 30046, 32083, 52051, 300004, 300015, 300033, 300037, 300038, 300045, 300054, 300057, 300066, 300068, 300072, 300081, 300082, 300084, 30008, 300091, 300107, 300109, 300120, 300122, 300141, 300142, 300149, 300150, 300156, 300157, 300207, 300208, 300209, 300210, 300211, 30004-1, 1, 3, 941055, 30047, 30049, 300146, 300212, 95742 & 941091.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • 제품 설명
    Ingenuity CT 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
  • Manufacturer