—#80544

Product

Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system.

FDA product code: MUE — Full Field Digital, System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
PMA numbers: P030010
Affected lot / code info: 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.

Why it was recalled

Image may appear dark, requiring repeat image acquisition.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2009-01-23
Posted by FDA: 2009-05-07
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.