Events

Recall of Device Recall Koodinat M/MP Patient Table used with Multistar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53353
  • Event Risk Class
    Class 2
  • Event Number
    Z-0167-2010
  • Event Initiated Date
    2009-07-01
  • Event Date Posted
    2009-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85318
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, x-ray, angiographic - Product Code IZI
  • Reason
    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
  • Model / 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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA