Z-0759-2023 Class II Ongoing

Recalled by GE Medical Systems, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
December 28, 2022
Initiation Date
November 10, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
250 units

Product 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).

Reason for Recall

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.

Distribution Pattern

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.

Code Information

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)