Events

Rappel de Device Recall SEIMENS Axiom Luminos TF and Sireskop SD

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Medical Solutions USA, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56256
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2222-2010
  • Date de mise en oeuvre de l'événement
    2010-07-13
  • Date de publication de l'événement
    2010-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93079
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Cause
    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.
  • 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.

Device

Device Recall SEIMENS Axiom Luminos TF and Sireskop SD
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: all 50 US states and PR.
  • Description du dispositif
    SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA