Z-0759-2023 Class II Ongoing
Recalled by GE Medical Systems, LLC
— Waukesha, WI
FDA device recall Z-0759-2023 was initiated by GE Medical Systems, LLC on Nov 10, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 250 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2022
- Initiation Date
- Nov 10, 2022
- 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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0759-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.