Koodinat M/MP Patient Table used with Multistar Model 6239003. The device is used as an Angiographic X-Ray...
Siemens Medical Solutions USA, Inc began a recall of Koodinat M/MP Patient Table used with Multistar Model 6239003. The device is used as an Angiographic X-Ray System on . The reason FDA records is "The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0167-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Koodinat M/MP Patient Table used with Multistar Model 6239003. The device is used as an Angiographic X-Ray System.
- Product code
- IZI System, X-Ray, Angiographic
- Reason for recall
- The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall.
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling False and Misleading
- 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.
- Quantity in commerce
- 362 units
- Distribution
- Nationwide Distribution.
- Product codes and lots
- 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.
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