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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