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U.S. Department of Health and Human Services

Class 2 Device Recall Coroskop XRay System

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 Class 2 Device Recall Coroskop XRay Systemsee related information
Date Initiated by FirmAugust 11, 2008
Date PostedNovember 04, 2008
Recall Status1 Terminated 3 on December 21, 2012
Recall NumberZ-0136-2009
Recall Event ID 49426
510(K)NumberK940484 
Product Classification angiographic x-ray system - Product Code IZI
ProductCoroskop X-Ray System, Model numbers 6258219 and 6379759.
Code Information Model number 6258219. Serial numbers: 1007, 1009, 1015, 1018, 1019, 1033, 1045, 1047, 1049, 1052, 1057, 1058, 1061, 1066, 1070, 1071, 1077, 1078, 1082, 1083, 1084, 1098, 1101, 1103, 1107, 1111, 1116, 1117, 1118, 1124, 1125, 1130, 1132, 1143, 1147, 1148, 1149, 1151, 1155, 1156, 1157, 1163, 1176, 1184, 1186, 1192, 1198, 1210, 1212, 1226, 1232, 1233, 1240, 1258, 1261, 1265, 1274, 1290, 1291, 1293, 1294, 1295, 1303, 1307, 1313, 1314, 1319, 1320, 1326, 1327, 1328, 1332, 1333, 1334, 1341, 1342, 1366, 1367, 1377, 1379, 1387, 1390, 1409, 1415, 1417, 1419, 1420, 1425, 1428, 1429, 1430, 1433, 1436, 1441, 1444, 1445, 1447, 1448, 1454, 1457, 1462, 1467, 1468, 1475, 1484, 1485, 1487, 1496, 1498, 1499, 1491, 1495, 1502, 1512, 1520, 1522, 1523, 1525, 1531, 1532, 1541, 1544, 1546, 1549, 1550, 1557, 1559, 1563, 1564, 1576, 1585, 1586, 1587, 1588, 1589, 1594, 1597, 1604, 1607, 1609, 1610, 1612, 1613, 1614, 1617, 1618, 1625, 1627, 1629, 1630, 1637, 1642, 1644, 1648, and 1649. Model number 6379759 - Serial numbers 2002, 2005, 2008, 2012, 2015, 2016, 2019, 2020, 2021, 2022, 2024, 2027, 2029, 2030, 2033, 2035, 2036, 2039, 2041, 2045, 2047, 2049, 2050, 2052, 2057, 2065, 2066, 2069, 2070, 2072, 2075, 2076, 2079, 2087, 2089, 2091, 2094, 2098, 2099, 2101, 2104, 2108, 2123, 2127, 2130, 2136, 2137, 2138, 2143, 2147, 2149, 2150, 2154, 2156, 2161, 2163, 2171, 2172, 2174, 2175, 2178, 2180, 2181, 2182, 2183, 2185, 2186, 2189, 2191, 2192, 2193, 2197, 2202, 2203, 2208, 2209, 2215, 2224, 2226, 2229, 2239, 2240, 2247, 2249, 2252, 2253, 2255, 2260, 2263, 2264, 2265, 2268, 2269, 2270, 2271, 2272, 2273, 2279, 2285, 2289, 2306, 2307, 2309, 2311, and 2313.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
Manufacturer Reason
for Recall		Unintended movement of the system table and/or C arm.
FDA Determined
Cause 2		Software design
ActionSiemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.
Quantity in Commerce260 units
DistributionNationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZI
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