Events

Recall of AXIOM Luminos TF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49417
  • Event Risk Class
    Class 2
  • Event Number
    Z-0101-2009
  • Event Initiated Date
    2008-08-12
  • Event Date Posted
    2008-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73281
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Solid State X-Ray Imager - Product Code MQB
  • Reason
    Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.
  • 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.

Device

AXIOM Luminos TF
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    AXIOM Luminos TF, model number 10093902 || Intended to be used for procedures that involve high skin doses, which can result in deterministic effects.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA