Z-1757-2024 Class II Ongoing

5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.

Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns

All Compact 5000 series systems manufactured on or before 20-Dec-2023 and purchased with Deluxe and Premium Cart options. REF/UDI-DI/Serial Numbers: 505500 CV/795141/00884838116566/USN23P0684, USN23P0623, USN23P0624, USN23P0685, USN23P0720, USN23P0615, USN23P0627, USN23P0611, USN23P0683, USN23P0682, USN23P0625, USN23P0173, USN23P0164, US823P0231, USN23P0613, USN23P0172, USN23P0721, USN23P0410, USN23P0612, USN23P0614, USN23P0171, US623P0141, US823P0233, US423P0844, US523P1060, US523P1061, US523P1750, US523P2536, US523P2537, US523P2672, US523P2673, US423P0842, US623P0140, US423P0759, US623P0142, US623P0230, US623P0485, US623P0486, US623P0740, US623P0790, US623P0791, US623P0792, US623P0866, US623P0867, US423P0843, US623P0966, US423P0672, US423P0673, US423P0674, US423P0712, US423P0757, US823P0132, US823P0232, US823P0318, US823P0319, US823P0320, US823P0321, US823P0322, US823P0507, US823P0508, US823P1857, US923P1161, US823P0129, US723P1919, US623P1072, US623P1403, US623P1483, US623P1606, US623P1607, US623P1608, US623P1609, US823P0131, US823P0029, US823P0128, US823P0127, US823P0033, US823P0032, US823P0030, US823P0028, US723P2256, US723P2154, US723P2153, US723P2152, US823P0130, US823P0031, USO23P2173, USO23P2065, US723P1242, US723P1243, US723P1342, US723P1343, US723P1241, US723P1240, USN23P0333, USN23P0332, US623P1450, US723P1766, USO23P0157, USO23P0156, USO23P0059, USO23P0058, US823P1743, US823P1744, US823P1745, US723P1582, US723P1872, US723P1583, USO23P2274, USO23P2064, USO23P2171, US623P1739, US723P1239, US723P1111, USN23P0330, USN23P0331, US923P0205, USN23P0051, US823P1767, US923P0207, US823P1770, US823P1769, US823P1251, US823P1229, US723P0393, US923P0421, USO23P2069; 5500 P/795143/00884838116573/USN23P0048, USN23P0050, USO23P2276, USO23P2275, US523P2372, US523P2538, US523P2406, US523P2405, US523P2374, US523P2373, US523P1837, US523P1838, US623P0741, US523P1839, US823P0744, US823P0745, US723P2257, US823P1030, US823P0877, US823P0548, US823P0547, US823P0546, US823P0511, US823P0509, US823P0317, US723P2258, US823P0510, US623P1486, US623P1485, US623P1741, US623P0969, US623P0968, US723P0809, US823P2055, US823P2054, US723P1584, US723P1472, US723P1471, USN23P0334, US823P2053, US723P1917, US923P0381, US823P1254, US723P0182, US723P0063, US623P2118, USO23P0171, US723P1918, US823P1250, USO23P2174, US723P0171, US723P0172, US623P2117, US723P0061, US723P0062, US723P0170, USN23P0753, US723P1809. US922P0888. US723P0596, US623P1738, US723P1112, US723P1113, US723P1767; 5500 W/795144/00884838116580/USN23P0628, USN23P0411, USN23P0174, USN23P0166, US523P2404, US623P0603, US623P0601, US423P0994, US423P0993, US423P0995, US623P0602, US623P2004, US623P1075, US723P0174, US723P0173, US623P2109, US623P2005, US922P0887, US623P1740; 5500 G/795145/00884838116597/USN23P0165, USN23P0053, USO23P1901, USO23P2068, USN23P0686, USN23P0414, USN23P0413, USN23P0412, USN23P0335, US523P2674, US523P2800, US523P2798, US523P2799, US623P0318, US623P0395, US623P0394, US623P0393, US623P0319, US623P0229, US623P0228, US623P0019, US623P0018, US623P0017, US623P0320, US523P2152, US523P2151, US523P2014, US523P2013, US523P2012, US523P1749, US523P1440, US523P1439, US823P0984, US823P0742, US823P0743, US823P0730, US823P0879, US823P1084, US823P0550, US823P0512, US823P0732, US723P2261, US723P2260, US723P2259, US623P1281, US623P1610, US623P1404, US623P1280, US623P1713, US823P0549, US823P1853, US823P1855, US823P1856, US823P1854, US723P1473, US723P1474, US723P1344, US723P1346, US723P1345, US723P1475, US823P1676, US823P0505, US723P2155, US723P2156, US823P1652, USN23P0626, US823P1678, US723P2157, USN23P0170, US723P1765, US623P2119, US823P1230, US723P0183, USO23P0172, USO23P0173, USO23P0174, US823P1677, US723P1763, US723P0064, US823P1747, US823P1746, US823P0741, USO23P2175, US723P1585, US923P0204, US723P0390, US723P0185, US723P0184, US723P0391, US723P0259, US723P0186, US723P0392, US723P0260, US723P0258, US723P0257, US723P0256, US923P0419, USN23P0049, US423P0714, US523P0946, US223P0651, US723P0599, US723P0598, US723P0597, US823P0880, US223P0650, US623P1863, US623P1864, USO23P2279, US723P1114, US723P1115, US723P1914, US723P1915, US723P1916, US623P2000, USO23P1805, US823P1768, USO23P2277, US823P2052, US723P0743, US723P0744, US823P2051, US723P0993, US723P0992, US923P0206, US823P1232, US923P0420, US723P1764, US823P1231, US923P0208; 5300 W/795146/00884838116603/US922P0893, USN23P0616, USN23P0177; 5300 P/795147/00884838116610/USN23P0724, US922P0892, USN23P0415, US723P0850, US823P0836, US723P0810, US623P0908, US623P2124, US623P2123; 5300 G/795148/00884838116627/US922P0891, US823P0230, US823P0228, US623P0484, US823P0229, USO23P2070, USO23P2176, US723P1586, USN23P0175, USN23P0176, US723P0600, USN23P0052