{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73281", "product_res_number": "Z-0101-2009", "event_date_initiated": "2008-08-12", "event_date_posted": "2008-10-10", "recall_status": "Terminated", "event_date_terminated": "2009-10-05", "res_event_number": "49417", "product_code": "MQB", "k_numbers": [ "K051602" ], "product_description": "AXIOM Luminos TF, model number 10093902\n\nIntended to be used for procedures that involve high skin doses, which can result in deterministic effects.", "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.", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "51 Valley Stream Pkwy", "city": "Malvern", "state": "PA", "postal_code": "19355-1406", "additional_info_contact": "Michael VanRyn\n610-219-6300", "reason_for_recall": "Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.", "root_cause_description": "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.", "product_quantity": "211 units", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K162504", "K200622", "K103348", "K042821", "K212269", "K070563", "K131211", "K161942", "K190311", "K200787", "K162178", "K201247", "K142003", "K220668", "K013138", "K020635", "K243556", "K122919", "K140771", "K153318", "K171417", "K212051", "K191939", "K161966", "K201528", "K153312", "K172435", "K190368", "K993861", "K181526", "K220510", "K050810", "K203849", "K121838", "K153401", "K111305", "K172681", "K082494", "K180809", "K240371", "K061538", "K062221", "K252911", "K042791", "K073056", "K250665", "K130377", "K103599", "K153464", "K161459", "K133524", "K102619", "K181003", "K171138", "K112132", "K210919", "K050987", "K162552", "K073165", "K003256", "K213307", "K090672", "K023586", "K133693", "K141271", "K072983", "K130464", "K171485", "K113449", "K212553", "K101289", "K223267", "K140235", 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