Volver al buscador
FDAFDA · Alimentos y medicamentos·N.º oficial Z-1757-2024

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.

Publicado el 15 de mayo de 2024 · Inicio del retiro: 23 de marzo de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips Ultrasound, Inc.
Distribuidor
Worldwide - US Nationwide distribution including in the states of CA, CO, CT, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, NC, NH, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA and the countries of Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Lithuania, Netherlands, New Zealand, Oman, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United Arab Emirates.
Lote
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, US723P05
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta