—#73281

Product

AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that involve high skin doses, which can result in deterministic effects.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051602
Affected lot / code info: Serial numbers: 1100, 1101, 1102, 1104, 1105, 1106, 1108, 1109, 1110, 1201, 1204, 1205, 1206, 1207, 1208, 1209, 1210, 1211, 1212, 1214, 1215, 1216, 1217, 1218, 1219, 1222, 1224, 1225, 1229, 1230, 1232, 1233, 1237, 1238, 1239, 1241, 1242, 1245, 1246, 1247, 1248, 1249, 1251, 1252, 1254, 1255, 1256, 1258, 1260, 1261, 1262, 1264, 1265, 1266, 1267, 1450, 1451, 1452, 1453, 1454, 1455, 1456, 1457, 1458, 1459, 1460, 1461, 1462, 1463, 1464, 1465, 1468, 1469, 1471, 1472, 1473, 1476, 1477, 1478, 1479, 1480, 1481, 1482, 1483, 1484, 1485, 1486, 1487, 1488, 1489, 1490, 1491, 1494, 1495, 1496, 1497, 1498, 1499, 1500, 1501, 1502, 1503, 1505, 1506, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1517, 1518, 1519, 1520, 1521, 1522, 1523, 1524, 1525, 1527, 1528, 1529, 1530, 1532, 1533, 1534, 1535, 1536, 1537, 1538, 1539, 1540, 1541, 1542, 1543, 1544, 1545, 1547, 1548, 1549, 1550, 1551, 1552, 1553, 1555, 1556, 1559, 1560, 1562, 1563, 1564, 1567, 1568, 1569, 1570, 1571, 1572, 1574, 1575, 1576, 1577, 1578, 1581, 1701, 1702, 1703, 1704, 1705, 1706, 1707, 1708, 1709, 1710, 1711, 1712, 1713, 1714, 1715, 1716, 1717, 1718, 1719, 1720, 1721,1722, 1723, 1724, 1725, 1726, 1727, 1728, 1729, 1730, 1731, 1732, 1733, 1734, 1736, 1738, 1739, 1740, 1741, 1743, 1744, 1745, and 1746.

Why it was recalled

Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.

Root cause (FDA determination)

Device Design

Action the firm took

The recalling firm was made aware of a potential problem with the device from the manufacturer in Germany. The recalling firm sent a copy of the Customer Safety Advisory Notice, dated June 18, 2008, received from Germany to their customers. The recalling firm has representatives visiting each location to modify the units.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2008-08-12
Posted by FDA: 2008-10-10
Terminated: 2009-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.