Class 2 Device Recall SEIMENS Axiom Luminos TF and Sireskop SD

• Date Initiated by Firm: July 13, 2010
• Date Posted: August 13, 2010
• Recall Status: Terminated on September 29, 2012
• Recall Number: Z-2222-2010
• Recall Event ID: 56256
• 510(K)Number: K062623 K051602
• 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 PA 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 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.