Siemens Medical Solutions USA, Inc Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system. Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Siemens Medical Solutions USA, Inc is recalling Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The dev due to Image may appear dark, requiring repeat image acquisition.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Image may appear dark, requiring repeat image acquisition.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026