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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0753-2023

Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Publicado el 28 de diciembre de 2022 · Inicio del retiro: 10 de noviembre de 2022

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Medical Systems, LLC
Distribuidor
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, 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, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
Lote
Model Number (System ID): H45021LD (VS6R0610, VS60368, VS6253, VS6229, VS60870, VS60838, VS627, VS671, VS6332, VS60647, VS629, VS60084, VS6302, VS674, VS6423, VS6411, VS6R0161, VS6634, VS682, VS60841, VS694, VS6341, VS6R0202, VS67633, VS5956VS5, BG4575US01, 604557VS6A, 819732VS6, 403541VS6A, 905523VS6, 416431VS6A, 905884VS6A, 647938VS6A, 705674VS6B, 705674VS6A, 604588VS6B, 604588VS6A, 416597VS6, HR4052US04, HR4179US01, CZ6302US01, CZ6267US01, CZ4031US21, CZ4024US08, CZ6112US02, CZ4031US18, CZ6256US01, CZ6240US01, USM4474502, 145865U002, 120008U030, 2195878U01, 142540U001, 2090670U02, 105827U235, 1926826U02, 818670U341, 800830U451, H1039US19, H2015US20, H4044US04, H1383US33, H2115US05, H4850US01, B5343402, LV4046US01, LT4001US05, LT4000US28, LT4070US01, LT4000US26, LT4000US25, ALR0440, AMS1047, AMS1046, GRN01412, GRN01411, GRN01410, IJM0240, LDN0170, UTR2141, PL2263US01, PL1736US03, PL1623US01, PL2217US01, PL1107US02, PL1006US06, PL1893US02, RO4159US02, RO4341US01, RO4334US02, RU1591US10, RU1106US22, RU1295US14, RU1295US15, RU1018US12, RU1695US02, RU3298US01, RU3299US01, RU1653US02, RU3431US01, RU1553US03, SK4206US02, SI4077US02, SI4077US03, SI4077US04, MPX76304, ME597504, A020US07, P31025UL05, 26011ULT04, 27005ULT06, 45009ULT01, 48015ULT01); H45021LJ (VS600103, VS61226, VS6329VS6, 082438070075, 082438070090, 082438160133, 082438180028, 082438090132, 082438090133, 082438090134, 082438220039, 082438290035, 082438010038, 082438150038, 082438160106, 082438180032, 082438180048, 082438270034, 082438270035, 082438270033, 082438070063, 082438290036, 082438290040, 082438220027, 082438210053, 082438160154, 082438130074, 082438130065, 082438130071, 082438130079, 082438140075, 082438070083, 082438050033, 082438140088, 082438210057, 082438310058, 082438310064, 082438280007, 082438290044, 082438160119, 082438160166, 110256U011, 2258373U01, 083038821002811, 083038841101714, 083038065102678, 083038105104829, 083038005104569, 083038005746413, UX9054, UXA012, UX9053, UXA028, UXA100, UX9098, UX8014, UXA009, UXA042, UX9090, UXA073, UXA024, UXA033, UX8032, UX9088, UX8034, UX8026, UX9077, UX9085, UX9057, UXA029, UX9092, UXA017, UXA001, UX9064, UX9066, UX8021, UX9079, UXA002, UX8005, UX8019, UX8008, UX9078, UX8044, UX9062, UX8036, UX8037, UX8049, UXA020, UX9068, UXA047, UX9087, UX9052, UX9051, UXA072, UX8018, UXA048, UX9060, UXA075, UX9081, UX8035, UX9086, UXA045, UX8003, UX8040, UX8007, UX9063, UX8004, UX8041, UX9061, UX9056, UX8025, UX9084, 0843384096, PL1232US03, PER13818, RU7430US03, RU3297US01, 0856380121, 34197ULT01, VS6578VS6); H45031EB (VS61302, VS6918, VS60793, VS61205, VS62007, 6061, VS61308, VS61866, VS61128, VS6R0695, VS61502, VS61498, 5864, 6120, VS61126, VS61420, VS60960, VS60361, VS60344, VS61334, VS61137, VS61830, VS61179, VS61740, VS61095, VS61331, VS6R0359, VS61213, VS6MB1686, VS6MB1339, VS6R1049, VS61115, VS60965, VS60988, VS61140, VS61244, VS61315, VS61345, VS61839, VS61231, VS61474, VS60994, VS61344, VS61033, VS60980, VS61941, VS61988, VS61968, VS60972, VS6666, VS61121, VS61116, VS61630, VS61629, VS60983, VS60999, VS61199, VS61098, VS60267, VS62160, VS61131, VS61953, VS61134, VS61012, VS61811, VS61211, VS61249, VS61592, VS61596, VS61449, VS61109, VS61318, VS61989, VS61100, VS61197, VS61441, VS61432, VS61283, VS61380, VS61317, VS61603, VS61585, VS61826, VS61661, VS61635, VS61939, VS61293, VS61007, VS61014, VS61437, VS61426, VS61374, VS61645, VS61299, VS61608, VS61364, VS61384, VS61371, VS6MB1248, VS63929VS6, 091136DEMO2467, 0911367150, AP5187US04, AP8694US01, AP0514US02, AH5287US10, AP0341US01, AP6694US01, AH0132US31, AH0132US32, AH0132US33, AP7099US01, AH0101US76, AH5848US61, AH4660US28, AH5848US57, 140024US18, 080053US03, 010028US02, 030344US02, 686348US01, 220166US14, 110037US13, 210002US44, 090009US02, 030018US07, 300013US06, 030029US08, 030029US10, 2847741, VS68335VS6, VS63428VS6, VS63748VS6, VS62261VS6, VS61716VS6, VS61568VS6, VS63483VS6, VS63225VS6, VS68332VS6, VS61721VS6, VS63147VS6, VS63677VS6, VS63676VS6, VS63514VS6,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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