Events

Recall of Device Recall Siemens Mammomat Novation DR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51494
  • Event Risk Class
    Class 2
  • Event Number
    Z-1233-2009
  • Event Initiated Date
    2009-01-23
  • Event Date Posted
    2009-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80544
  • Notes / Alerts
    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.
  • Extra notes in the data
    Full field digital mammography system - Product Code MUE
  • Reason
    Image may appear dark, requiring repeat image acquisition.
  • Action
    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
  • Model / 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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA