Events

Retiro De Equipo (Recall) de Device Recall Koodinat M/MP Patient Table used with Multistar

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
    53353
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0167-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85318
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Causa
    The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall.
  • Acción
    The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.

Device

Device Recall Koodinat M/MP Patient Table used with Multistar
  • Modelo / Serial
    Model number 6239003. Serial numbers: 1024, 1036, 1050, 1051, 1054, 1058, 1071, 1072, 1076, 1087, 1093, 1094, 1095, 1098, 1109, 1110, 1112, 1120, 1123, 1128, 1133, 1150, 1151, 1162, 1177, 1179, 1189, 1190, 1194, 1199, 1206, 1209, 1215, 1222, 1230, 1231, 1247, 1250, 1254, 1256, 1265, 1275, 1279, 1285, 1292, 1296, 1297, 1298, 1303, 1305, 1306, 1307, 1309, 1310, 1313, 1319, 1320, 1322, 1331, 1335, 1336, 1341, 1344, 1347, 1348, 1350, 1354, 1358, 1361, 1365, 1369, 1375, 1389, 1390, 1401, 1405, 1411, 1418, 1422, 1426, 1429, 1431, 1436, 1441, 1447, 1448, 1451, 1457, 1462, 1464, 1467, 1478, 1485, 1497, 1498, 1501, 1504, 1512, 1513, 1517, 1518, 1520, 1522, 1524, 1534, 1537, 1543, 1548, 1550, 1552, 1556, 1557, 1559, 1564, 1566, 1569, 1570, 1573, 1577, 1581, 1587, 1590, 1605, 1607, 1615, 1617, 1618, 1619, 1620, 1626, 1628, 1632, 1634, 1650, 1657, 1663, 1664, 1666, 1670, 1674, 1682, 1689, 1701, 1708, 1711, 1716, 1718, 1720, 1722, 1727, 1728, 1731, 1732, 1740, 1744, 1751, 1754, 1756, 1757, 1761, 1768, 1771, 1776, 1777, 1779, 1780, 1781, 1783, 1784, 1789, 1792, 1794, 1801, 1803, 1805, 1810, 1813, 1817, 1819, 1820, 1821, 1822, 1824, 1829, 1832, 1835, 1841, 1844, 1847, 1850, 1851, 1852, 1858, 1865, 1866, 1867, 1871, 1873, 1875, 1877, 1879, 1880, 1881, 1886, 1888, 1890, 1895, 1896, 1906, 1908, 1915, 1918, 1923, 1924, 1925, 1926, 1932, 1934, 1938, 1942, 1952, 1954, 1962, 1976, 1981, 1984, 1989, 1998, 2003, 2007, 2008, 2009, 2013, 2015, 2016, 2017, 2021, 2024, 2025, 2028, 2035, 2040, 2041, 2042, 2044, 2053, 2055, 2060, 2061, 2068, 2071, 2074, 2076, 2078, 2079, 2080, 2082, 2084, 2085, 2089, 2092, 2095, 2096, 2100, 2104, 2107, 2118, 2120, 2121, 2123, 2124, 2125, 2126, 2127, 2128, 2129, 2140, 2143, 2146, 2162, 2163, 2170, 2177, 2179, 2181, 2183, 2184, 2194, 2196, 2200, 2202, 2212, 2213, 2215, 2218, 2219, 2223, 2225, 2227, 2228, 2230, 2231, 2235, 2238, 2244, 2246, 2248, 2253, 2254, 2256, 2258, 2261, 2263, 2266, 2267, 2271, 2277, 2280, 2294, 2300, 2301, 2318, 2323, 2324, 2326, 2329, 2335, 2336, 2341, 2344, 2346, 2347, 2348, 2350, 2351, 2352, 2353, 2357, 2359, 2361, 2368, 2372,2376, 2378, 2380, 2381, 2388, 2390, 2391, 2392, 2394, 2398, 2399, 2401, 2403, 2418, 2461, 2507, 2690, 2742, 3426, 4995, and 11714.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Koodinat M/MP Patient Table used with Multistar Model 6239003. || The device is used as an Angiographic X-Ray 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