Events

Retiro De Equipo (Recall) de Device Recall Siemens Mammomat Novation DR

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    51494
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1233-2009
  • Fecha de inicio del evento
    2009-01-23
  • Fecha de publicación del evento
    2009-05-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80544
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Full field digital mammography system - Product Code MUE
  • Causa
    Image may appear dark, requiring repeat image acquisition.
  • Acción
    A Customer Safety Advisory Notice dated December 16, 2008 was issued to affected customers via Update Instructions SP040/08/S. The letter described the potential issue and provided instructions to avoid its occurrence. A software update to correct the issue is currently being developed and will be installed on affected systems when it becomes available.

Device

Device Recall Siemens Mammomat Novation DR
  • Modelo / Serial
    Serial Numbers: 1009, 1024, 1035, 1038, 1039, 1044, 1045, 1046, 1047, 1054, 1055, 1060, 1105, 1107, 1108, 1114, 1208, 1209, 1210, 1211, 1212, 1214, 1216, 1217, 1220, 1224, 1227, 1228, 1229, 1230, 1234, 1237, 1240, 1243, 1254, 1255, 1258, 1259, 1260, 1261, 1264, 1265, 1267, 1268, 1269, 1270, 1271, 1305, 1307, 1311, 1315, 1317, 1318, 1319, 1320, 1321, 1322, 1324, 1325, 1327, 1329, 1330, 1332, 1334, 1336, 1339, 1340, 1341, 1343, 1344, 1346, 1347, 1348, 1353, 1355, 1357, 1360, 1362, 1366, 1368, 1373, 1376, 1377, 1379, 1382, 1384, 1388, 1392, 1403, 1412, 1427, 1430, 1434, 1435, 1438, 1439, 1441, 1442, 1443, 1446, 1447, 1448, 1449, 1450, 1453, 1454, 1456, 1459, 1460, 1462, 1465, 1466, 1467, 1468, 1469, 1470, 1478, 1479, 1480, 1482, 1486, 1487, 1488, 1494, 1495, 1496, 1497, 1552, 1555, 1557, 1558, 1560, 1562, 1563, 1564, 1567, 1568, 1570, 1571, 1572, 1577, 1578, 1581, 1583, 1588, 1591, 1595, 1597, 1598, 1600, 1601, 1602, 1608, 1610, 1612, 1615, 1616, 1620, 1623, 1624, 1626, 1632, 1634, 1635, 1636, 1637, 1640, 1641, 1642, 1643, 1644, 1645, 1649, 1651, 1652, 1659, 1666, 1668, 1669, 1670, 1671, 1672, 1674, 1675, 1678, 1680, 1687, 1690, 1691, 1692, 1693, 1695, 1696, 1698, 1699, 1704, 1705, 1715, 1716, 1717, 1719, 1720, 1723, 1725, 1726, 1727, 1728, 1729, 1732, 1733, 1734, 1735, 1738, 1739, 1740, 1741, 1742, 1747, 1753, 1754, 1755, 1756, 1757, 1760, 1761, 1762, 1763, 1765, 1767, 1769, 1772, 1773, 1778, 1779, 1780, 1784, 1785, 1788, 1791, 1795, 1797, 1799, 1801, 1804, 1806, 1809, 1811, 1814, 1815, 1816, 1817, 1821, 1822, 1823, 1824, 1825, 1826, 1830, 1831, 1832, 1833, 1837, 1838, 1840, 1841, 1844, 1845, 1846, 1847, 1851, 1852, 1853, 1859, 1861, 1862, 1865, 1871, 1874, 1875, 1877, 1878, 1879, 1880, 1881, 1897, 1898, 1899, 1900, 1901, 1905, 1906, 1907, 1908, 1909, 1910, 1911, 1912, 1913, 1914, 1915, 1917, 1919, 1921, 1922, 1928, 1929, 1933, 1934, 1935, 1936, 1939, 1940, 1941, 1942, 1943, 1944, 1949, 1950, 1953, 1955, 1956, 1958, 1959, 1961, 1962, 1964, 1968, 1969, 1970, 1971,1972, 1973, 1974, 1975, 1976, 1980, 1981, 1983, 1984, 1985, 1986, 1988, 1989, 1991, 1993, 1994, 1996, 1998, 2001, 2002, 2003, 2004, 2006, 2007, 2008, 2009, 2011, 2012, 2013, 2016, 2017, 2019, 2020, 2023, 2024, 2026, 2028, 2031, 2032, 2033, 2035, 2040, 2041, 2046, 2056, 2057, 2058, 2061, 2062, 2064, 2065, 2066, 2067, 2071, 2072, 2075, 2078, 2079, 2080, 2082, 2083, 2086, 2087, 2088, 2089, 2094, 2095, 2096, 2099, 2100, 2102, 2103, 2104, 2105, 2107, 2108, 2109, 2110, 2111, 2118, 2120, 2121, 2122, 2126, 2128, 2129, 2130, 2131, 2132, 2133, 2135, 2136, 2137, 2142, 2144, 2145, 2146, 2147, 2149, 2152, 2153, 2156, 2159, 2162, 2163, 2164, 2165, 2166, 2168, 2169, 2170, 2171, 2172, 2173, 2176, 2179, 2180, 2182, 2183, 2184, 2185, 2186, 2187, 2188, 2189, 2190, 2191, 2195, 2196, 2197, 2198, 2199, 2200, 2201, 2202, 2203, 2204, 2205, 2206, 2207, 2208, 2209, 2211, 2212, 2213, 2214, 2215, 2216, 2217, 2218, 2219, 2222, 2223, 2224, 2225, 2226, 2227, 2228, 2229, 2233, 2234, 2236, 2237, 2240, 2241, 2244, and 2245.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. || The device is used for full field digital mammography system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA