Recall Z-1233-2009
Siemens Medical Solutions USA, Inc · initiated January 23, 2009
Product
Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system.
Codes / 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…
Reason for recall
Image may appear dark, requiring repeat image acquisition.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-1233-2009
- Initiated
- January 23, 2009
- Posted by FDA
- May 7, 2009
- Terminated
- March 19, 2013
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- Quantity
- 497 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA