Events

Rappel de Device Recall Koodinat M/MP Patient Table used with Multistar

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
    53353
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0167-2010
  • Date de mise en oeuvre de l'événement
    2009-07-01
  • Date de publication de l'événement
    2009-11-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85318
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Cause
    The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    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
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA