Vivid q N ultrasound. Not marketed in the US. 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).
Enforcement
- Recall Number
- Z-0759-2023
- Event ID
- 91139
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE Medical Systems, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 28, 2022
- Initiation Date
- November 10, 2022
- Classification Date
- December 22, 2022
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States
Description
Vivid q N ultrasound. Not marketed in the US. 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).
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.
No US Distribution. Model Number (System ID): H45571BK (DZ1315US08, VQ50927VQ, 835385929, 0835385937, IQ1398US05, IQ1398US04, IQ1398US03, IQ1398US02, A6193101, JO4026US01, JO4034US01, KE1070US01, KW1018US27, KT1066US01, LY1076US02, OM1000US04, OM1042US09, OM1042US08, OM1010US10, PK1367US01, QA1062US02, SA1345US06, SA2072US19, SA2158US09, SA2329US08, SA2308US02, SA1199US04, SA1199US03, SA1012US48, SA1058US63, SA1058US64, ZA2466US01, ZA2466US02, ZA2500US01, ZA2483US01, ZA2841US01, ZA3242US03, ZA2416US02, ZA1015US07, ZA3258US01, ZA1177US02, ZA2481US01, ZA2461US01, ZA2499US01, ZA2430US01, ZA2498US01, ZA2976US02, ZA2504US01, ZA2316US03, ZA2314US02, ZA2449US01, ZA2448US02, ZA2509US01, TN1279US02, 34118ULT34, 33054ULT01, P65021UL06, AE1006US18, AE1131US02, AE1025US06, AE1149US18, AE1149US16); H45571ZC (DZ1292US08, DZ1473US02, DZ1534US04, VQ55477VQ, DK1167US77, EG1621US32, EG1980US01, ET1031US01, 083038600786615, 083038602082015, 083038603381415, 5512UL1025, 5512UL0912, 5512UL0914, 5512UL0913, 835385974, 5512UL0838, 5512UL0839, 0835385958, 0835385967, 0835385972, 5512UL0276, 5512UL0003, 5512UL0408, 5512UL0256, 5512UL0843, 5512UL0236, 5512UL1346, 5512UL1345, 5512UL0483, IQ1580US01, IQ1297US04, IQ1399US01, IQ1398US01, A6384301, KE6093US01, KE1000US07, KE6031US01, KE6111US01, KW1055US19, KW1065US06, KW1002US04, KW1011US39, KW1011US31, KW1011US41, KW1011US40, KW1005US26, KW1126US01, KW1004US39, LB1050US06, LB1055US07, LB1055US06, LB1055US04, LB1055US05, LB1148US06, 1553UL0170, 1553UL0229, 1553UL0308, 1553UL0320, 1553UL0230, 1553UL0092, 1553UL0070, MU1018US01, NA1043US01, NG1186US02, OM1070US01, OM1073US03, OM1042US10, OM1065US06, OM1007US14, PK1300US29, PL8358US01, QA1020US08, QA1020US07, SA2330US05, SA2128US03, SA1060US18, SA2045US13, SA2045US09, SA2045US10, SA2045US11, SA2122US04, SA2072US20, SA2385US06, SA2329US13, SA1005US33, SA1005US34, SA1005US35, SA1118US21, SA1245US04, SA1101US06, SA2107US05, SA2107US02, SA2107US04, SA2107US03, SA2159US04, SA2513US08, SA2485US01, SA1012US56, SA1012US57, SA1034US45, ZA2899US01, ZA2745US01, ZA2858US01, ZA2786US01, ZA2279US02, ZA2577US01, ZA2787US01, ZA3145US01, ZA2765US01, ZA2626US01, ZA1047US01, ZA2656US02, ZA2670US02, ZA2800US01, ZA1850US02, ZA2699US01, ZA1030US17, ZA2545US02, ZA2902US01, ZA2986US01, ZA2767US04, ZA2595US01, ZA2702US01, ZA2970US05, ZA2900US01, ZA2793US01, ZA2788US01, ZA2726US02, ZA2754US01, ZA2735US01, ZA2789US01, ZA2602US01, ZA2955US01, ZA1030US16, ZA1018US01, ZA2141US02, ZA2141US01, ZA2567US02, ZA2940US01, ZA1850US03, ZA2685US01, ZA2177US02, ZA2137US02, ZA2976US01, ZA2965US01, ZA2273US03, ZA2818US01, ZA2772US02, ZA2749US01, ZA2853US01, ZA2819US01, ZA2851US01, ZA2687US02, 138691US01, P06043UL12, 06002ULT36, 06008ULT57, 06002ULT43, 16032ULT12, 25001ULT20, 34418ULT15, 34373ULT18, 34006ULT26, 34006ULT23, 35001ULT19, 46003ULT14, 33043ULT03, 33043ULT02, 59019ULT07, P71003UL13, P07012UL07, P65005UL04, UG1051US04, AE1353US03, AE1003US16, AE1477US04, AE1160US10, AE1477US05, AE1540US01, AE1554US01, AE1388US04, AE1062US02, AE1009US21, AE1009US22, AE1017US14, AE1017US19, AE1045US11)
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.
250 units