Events

Retiro De Equipo (Recall) de Device Recall SEIMENS Axiom Luminos TF and Sireskop SD

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56256
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2222-2010
  • Fecha de inicio del evento
    2010-07-13
  • Fecha de publicación del evento
    2010-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93079
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: all 50 US states and PR.
  • Descripción del producto
    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
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA