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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