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FDAFDA · Food and drugs·Recall number 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).

Published December 28, 2022 · Recall initiated: November 10, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Medical Systems, LLC
Distributor
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.
Lot
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,
Risk classification
Class II
Area (FDA)
device
Country
United States

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