GE Medical Systems, LLC: Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstet

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.

Details from the source

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: 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, Bahrai Quantity: 7,931 units Lot/code info: Model Number (System ID): H45021A (VI4552, VI351); H45021AF (VI1246, VI327, VI1415, VI256, VI00887, VI1119, VI000832, VI0468, VI666, VI1658, VI1263, VI1676, VI1673, VI1261, VI689, VI921, VI1148, VI511, VI050852, VI1295, VI1166, VI1247, VI1536, VI730, VIMB00435, VI431, VI2397, VI1029, VI554, VI1020, VI0658, VI1432, VI51073, VI880, VI1199, VI994, AVHSE20751, VI311, VI379, VI1256, VI1214, VI345, VI193, VI336, VI1097, VI853, VI1488, VI848, VI1017, VI739, VI1258, VI248, VI732, VI148, VI1410, VI1234, VI697, VIR55546, VI153, VI562, EPSW59BF, VI1452, VI669, VI342, VI1118, VI1259, VI1529, VI1394, VI055240, VI963, VI651, VI1437, VI1517, VI50194, VI257, VI824, VI621, VI622, 393204, VI623, VI0579, VI1446, VI1552, VI374, VI906, VI1241, VI132, VI797, VI907, VI1236, VI1565, VI638, 912535VIVID, VI1321, VI526, VI258, VI261, VI50588, VI303, VI000459, VI000228, VI914, VI055696, VI1600, VI816, VI896, VI684, VIV0704, VI1240, VI365, VI358, VI653, VI230, VI680, VI480, VIMB000788, VI1205, VI1531, VI949, VI1284, VI282, VI660, VI463, VI643, VI551, VI113, VI573, VI1363, VI2306, VI538, VI208, VI1506, VI1509, VI1508, VI1507, VI711, VIV1530, VI0696, VI1451, VI654, VI1154, VI1698, VI1279, VI456, VI457, VI808, VI905, VI1233, VI692, VI1435, VI417, VI2495, VI927, VI1397, VI1558, VI986, VI1858, VI1596, VI1235, VI277, VIR00196, VI170, VI471, VI1571, VI21206, VI670, VI215, VI945, VI0789LO, VI841, VI348, VI1684, VI1030, VI1367, VI312, VI1539, VI838, VI1212, VI281, VI619, VI620, VI655, VI703, VI1265, VI1301, VI147

UPC codes

082438040068, 082438040103, 082438230020, 082438130037, 82438210030, 082438210056, 082438160153, 82438090144, 82438040157, 82438210035, 85212930569, 082438090138, 082438070070, 082438160143, 082438040077, 082438040093, 082438040094, 082438040112, 082438040116, 082438040119, 082438040127, 082438160122, 082438160126, 082438040102, 082438280010, 082438120361, 082438150040, 082438160113, 082438160134, 082438110046, 082438110050, 082438100131, 082438140083, 082438290017, 082438290030, 082438290037, 082438110038, 082438150049, 082438090129, 082438130051

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.