Z-1233-2009

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

Name: Z-1233-2009 Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is...
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-01-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-01-23 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system on 2009-01-23. The reason FDA records is "Image may appear dark, requiring repeat image acquisition". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1233-2009
Status: Terminated
Initiated: 2009-01-23
Posted: 2009-05-07
Terminated: 2013-03-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Image may appear dark, requiring repeat image acquisition.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 497 units
Distribution: Nationwide Distribution.
Product codes and lots: 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 code MUE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)