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U.S. Department of Health and Human Services

Class 2 Device Recall SEIMENS Axiom Luminos TF and Sireskop SD

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 Class 2 Recall
SEIMENS Axiom Luminos TF and Sireskop SD
see related information
Date Posted August 13, 2010
Recall Status1 Terminated on September 29, 2012
Recall Number Z-2222-2010
Recall Event ID 56256
Premarket Notification
510(K) Numbers
K051602  K062623 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system.
Code Information Model numbers 3111668, 3111676, 8890407, 8890415, 10093902. Serial numbers 35059, 35069, 24026, 24030, 41003, 1977, 24020, 34043, 35054, 25014, 1758, 34164, 51041, 34158, 1750, 36038, 36012, 34206, 71135, 24013, 35022, 33036, 36075, 36116, 51059, 1568, 34022, 34042, 36096, 34079, 21037, 34179, 34005, 34188, 34160, 22002, 24031, 1821, 31030, 1471, 31061, 34032, 1830, 1494, 1803, 36010, 41020, 25008, 71011, 31008, 31016, 34161, 36045, 1782, 1906, 1975, 1781, 71069, 71087, 1484, 1452, 1458, 1459, 21029, 1264, 1712, 51012, 21103, 1268, 34070, 34073, 34111, 34210, 36063, 71133, 1988, 1806, 1468, 31029, 31031, 31032, 35052, 1567, 36047, 36059, 1224, 51040, 51055, 2023, 21115, 34181, 36015, 51020, 1502, 1564, 26028, 36117, 1979, 1998, 21010, 34182, 34196, 34211, 35053, 71057, 1963, 71081, 24048, 34015, 36022, 1748, 21007, 1262, 1204, 1218, 1757, 26033, 1728, 21031, 2013, 34093, 33045, 35097, 41006, 1802, 1215, 1216, 34216, 35023, 1760, 21052, 35075, 35068, 71060, 1784, 71048, 1940, 1476, 1726, 1238, 33051, 2032, 26014, 36064, 1255, 21109, 24006, 24023, 1754, 1788, 51045, 1110, 1208, 71023, 34180, 34062, 51028, 71092, 1973, 34066, 34142, 31065, 34071, 2012, 21113, 36095, 1529, 1578, 1462, 1793, 1795, 1922, 1258, 1783, 71153, 33075, 34029, 35019, 35089, 36087, 1808, 71017, 71042, 24041, 71013, 71062, 71037, 1478, 1813, 51033, 1574, 34047, 51051, 71171, 71173, 24017, 51029, 32019, 34041, 34064, 1822, 71065, 51049, 36037, 24029, 31071, 36021, 36004, 31062, 34036, 34060, 34104, 32023, 33087, 35058, 26009, 2005, 36051, 35057, 26007, 31014, 36112, 1914, 1809, 1810, 33079, 34038, 34140, 1908, 71099, 35002, 71155, 1526, 1785, 1108, 1237, 1932, 24018, 1521, 34105, 34189, 71105, 34191, 1799, 71175, 1938, 35061, 25003, 31005, 36024, 1214, 34175, 51025, 1523, 32001, 32003, 32004, 71095, 1744, 1519, 33062, 35108, 35024, 36114, 1247, 1248, 36002, 21024, 32022, 33025, 34057, 36100, 71076, 22005, 34199, 1534, 41001, 33014, 1739, 71167, 71170, 34044, 1996, 31048, 35048, 51066, 1455, 71098, 35065, 35070, 31017, 31018, 36107, 25016, 1801, 71073, 26031, 1910, 1911, 1913, 34134, 21086, 51023, 21144, 1981, 34051, 34183, 2022, 1550, 34052, 51010, 71136, 1242, 34193, 51043, 71110, 34077, 1104, 31009, 1570, 1269, 33027, 34025, 35027, 35087, 23006, 71103, 21041, 1267, 24011, 2015, 2017, 1920, 24047, 1945, 34138, 34012, 35015, 35020, 71024, 1246, 71003, 1543, 24002, 1509, 35021, 34177, 71004, 21061, 32028, 1481, 51047, 36080, 1222, 36046, 1524, 36093, 71088, 71140, 34130, 34145, 24005, 71033, 35102, 71055, 33081, 25002, 21018, 31006, 34129, 34198, 35013, 36011, 36097, 31035, 1249, 51015, 21117, 24027, 31063, 1508, 1775, 71177, 1499, 21042, 34006, 71002, 1569, 71115, 21083, 31043, 21009, 1989, 1252, 1759, 1764, 1555, 32007, 34146, 33052, 34085, 34086, 71051, 71090, 1544, 51026, 31042, 1256, 1480, 1260, 1774, 36071, 36079, 34084, 25024, 1765, 1796, 21045, 36031, 34141, 1794, 1787, 36036, 31046, 31047, 1225, 71101, 36025, 1545, 71083, 41009, 21154, 34217, 35008, 71005, 36101, 1719, 1720, 34172, 34173, 41024, 71078, 71079, 71067, 34106, 71009, 71165, 33023, 1477, 34100, 51024, 36008, 71080, 1109, 34122, 33067, 35028, 35029, 71114, 71152, 35025, 35062, 34116, 1776, 1951, 33074, 71141, 71154, 1485, 1486, 1487, 1488, 33015, 34126, 1513, 24016, 1206, 1928, 33003, 21127, 1500, 1483, 1761, 1931, 1511, 31021, 24035, 51068, 71097, 1930, 71015, 33010, 1451, 1100, 1245, 2029, 1722, 1791, 1525, 1902, 1993, 1994, 1792, 1999, 1701, 41022, 71096, 1559, 71025, 51048, 36029, 1745, 33076, 1925, 35073, 1575, 34016, 1723, 34135, 41027, 41028, 71117, 71119, 71120, 71121, 1718, 33017, 24039, 71028, 22011, 23001, 36073, 34195, 34123, 21090, 34021, 1751, 32040, 1540, 2018, 1933, 1232, 71010, 71112, 36098, 71106, 1904, 51031, 51035, 51039, 1729, 34120, 1254, 1454, 1472, 32037, 33077, 34207, 71026, 35078, 71149, 34148, 71016, 1992, 34209, 71014, 21028, 71082, 71066, 1995, 35045, 36081, 36019, 36040, 24025, 71142, 71074, 1265, 21116, 1985, 71019, 32024, 33078, 1473, 1581, 51054, 1831, 35003, 36094, 33058, 34049, 25007, 36060, 24043, 25005, 1239, 1261, 1450, 1456, 1457, 1505, 1506, 31076, 31041, 31045, 34107, 1530, 34091, 1976, 1756, 1731, 36041, 23017, 21051, 26027, 1514, 71007, 36017, 24038, 34174, 1772, 1817, 51013, 71125, 32021, 34075, 71040, 1105, 71160, 35105, 1539, 33002, 51056, 1549, 21119, 35106, 1716, 34124, 1490, 71038, 23002, 23004, 33080, 1984, 2003, 71111, 41017, 32020, 71126, 71145, 1201, 1929, 34121, 36083, 1832, 36057, 34162, 41019, 21025, 71053, 1205, 1207, 41002, 1553, 1747, 2002, 71162, 24010, 24008, 1496, 33056, 71030, 34176, 1952, 1953, 2004, 1495, 1727, 1959, 1961, 1536, 35026, 35044, 21016, 36105, 34089, 32009, 41013, 41023, 71022, 1211, 1533, 34087, 71129, 2024, 1518, 1721, 21082, 71104, 36023, 1469, 26010, 36069, 51030, 1528, 1563, 1705, 1732, 1749, 2000, 21077, 21081, 24034, 34067, 34081, 34103, 71150, 34004, 51044, 1755, 34018, 24049, 1515, 71061, 23020, 21068, 34007, 34008, 35009, 36039, 71001, 26008, 34187, 71008, 34213, 34048, 33072, 1814, 71174, 1967, 1986, 1702, 36026, 51069, 32034, 1819, 1923, 1924, 33028, 36030, 35076, 35092, 34154, 34156, 34128,1818, 51017, 1489, 21143, 22003, 35090, 71043, 36042, 32025, 51052, 51064, 41010, 71091, 71139, 26030, 1941, 1733, 33064, 34034, 25031, 34098, 34147, 21132, 32039, 1955, 35100, 36005, 71018, 34139, 34205, 25020, 25022, 36111, 51011, 34150, 34068, 51063, 1532, 1730, 1907, 1230, 34102, 35051, 33037, 1767, 34028, 34171, 34017, 71181, 71075, 71147, 1212, 41014, 34159, 1577, 41029, 34014, 32027, 51050, 1956, 1217, 1969, 1980, 36061, 26025, 24009, 1517, 1936, 1937, 1482, 35110, 35114, 1962, 31028, 35056, 1828, 22009, 34035, 21055, 71123, 34001, 34002, 71124, 2026, 34118, 34031, 34046, 36043, 1461, 71100, 36067, 36068, 36070, 36086, 1520, 1946, 1909, 33054, 71163, 21011, 25015, 51058, 34197, 26005, 1241, 71063, 51009, 35049, 71032, 33033, 1948, 1453, 1740, 26026, 26029, 33005, 1102, 35018, 1826, 1734, 35074, 1724, 71059, 71179, 31070, 35039, 33060, 2030, 36090, 51037, 36099, 25006, 1987, 35032, 34186, 31044, 31072, 22001, 1547, 34090, 21015, 21038, 32032, 21022, 34152, 32005, 35050, 71161, 71158, 34094, 1491, 1753, 1209, 26001, 41012, 2025, 36092, 1746, 71159, 51061, 71045, 1548, 31038, 34095, 33046, 31078, 21070, 41026, 36110, 51004, 24015, 1926, 34163, 1562, 35030, 35031, 71102, 34178, 71180, 34110, 36077, 36020, 36018, 71020, 35064, 35081, 36053, 21139, 1464, 25053, 36066, 41007, 41018, 1717, 31025, 33022, 51007, 51008, 51065, 33006, 33007, 1812, 23013, 35055, 41008, 36034, 31027, 2020, 1743, 1770, 34208, 36028, 31011, 21089, 21114, 36027, 33063, 33032, 71157, 34020, 35095, 35101, 35085, 1807, 21074, 51022, 33008, 36048, 71166, 36055, 51036, 1556, 34011, 34167, 71006, 1983, 36050, 1460, 33049, 51070, 36009, 71146, 25019, 33029, 1738, 31074, 36054, 51057, 33057, 35091, 35093, 51003, 1804, 1978, 25001, 71148, 71156, 35080, 36076, 1229, 1571, 1833, 51046, 1497, 1541, 71116, 1942, 1944, 51002, 35014, 51001, 1522, 31066, 33001, 34045, 35016, 36065, 51019, 51016, 1972, 1551, 33038, 33055, 35040, 33004, 34054, 34143, 35038, 21050, 21094, 21153, 25026, 35111, 71064, 71128, 71131, 1947, 1711, 1707, 51005, 1535, 1715, 71108, 71068, 1479, 35107, 35006, 35067, 1527, 41005, 31033, 33086, 51060, 35046, 1725, 31060, 36089, 1233, 26024, 71137, 1704, 1736, 1834, 36091, 71027, 24032, 34058, 71144, 1798, 1823, 1935, 25017, 32033, 2009, 24040, 71086, 26016, 32017, 36049, 1957, 71089, 71151, 71070, 1560, 34212, 35086, 21121, 34065, 71109, 71130, 34201, 31024, 36052, 1965, 35072, 2019, 1982, 35063, 32006, 1990, 1538, 71122, 36001, 1498, 1503, 1507, 1797, 1901, 1219, 34076, 1546, 23021, 24042, 34055, 34061, 21145, 36058, 71035, 36056, 34127, 1827, 25029, 1703, 1790, 71113, 36035, 34157, 34114, 32038, 21112, 31073, 32030, 34078, 34166, 21035, 33011, 34192, 1829, 1101, 34003, 36044, 71021, 34019, 34215, 1572, 1777, 1210, 1576, 1912, 1939, 2027, 21120, 21155, 1708, 26006, 1966, 34185, 34190, 1106, 24021, 2021, 33043, 1501, 1542, 26017, 21023, 21098, 21133, 21157, 34112, 34115, 34117, 34136, 35034, 35096, 35112, 35113, 36013, 36102, 71029, 71058, 71072, 71084, 71138, 71164, 71168, 71169, 71172, 71178, 1706, 1762, 1771, 1773, 1789, 1800, 1949, 2028, 1927, 1824, 1974, 33012, 33042, 33021, 1778, 23014, 2008, 34200, 1964, 1997, 21053, 21072, 33061, 34219, 34220, 1950, 1958, 71034, 1710, 1780, 1752, 1465, 71039, 24012, 1251, 1915, 1903, 1917, 33016, 35071, 36003, 36108, 1266, 1512, 26022, 51021, 1709, 1779, 1741, 1552, 24007, 26012, 41011, 36033, 21071, 71127, 24045, 34033, 34097, 34074, 35007, 34108, 35060, 34133, 36007, 34040, 35005, 35011, 21150, 33069, 34027, 34214, 34037, 34184, 1713, 1714, 1954, 21044, 1537, 33082, 35041, 36115, 51018, 71046, 1510, 21102, 1463, 35115, 36032, 31080, 32011, 1960.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Meredith A. Adams
610-448-3237
Manufacturer Reason
for Recall
Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images.
FDA Determined
Cause 2
DESIGN: Device Design
Action Siemens Healthcare Sector sent an "Urgent Field Safety Notice" to consignees describing the issue and informing them to take specific precautions when performing interventional procedures to avoid fluids penetrating the system. The multi-functional handle (Opti Grip) will be replaced through implementation of Update Instructions AX030/10/S. The modified version of the handle resists fluids from entering the handle and prevents malfunction.
Quantity in Commerce 1296
Distribution Nationwide distribution: all 50 US states and PR.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
510(K)s with Product Code = MQB and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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