Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fe...
FDA Device Recall #Z-0759-2023 — Class II — November 10, 2022
Recall Summary
| Recall Number | Z-0759-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 10, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| 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.
Lot / 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)
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.