FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that involve high skin doses, which can result in deterministic effects.
- Recall number
- Z-0101-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that involve high skin doses, which can result in deterministic effects.
- Status
- Terminated
- Initiated
- 2008-08-12
- Posted
- 2008-10-10
- Terminated
- 2009-10-05
- Reason
- Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 211 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K051602"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28