FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Coroskop X-Ray System, Model numbers 6258219 and 6379759.
- Recall number
- Z-0136-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Coroskop X-Ray System, Model numbers 6258219 and 6379759.
- Status
- Terminated
- Initiated
- 2008-08-11
- Posted
- 2008-11-04
- Terminated
- 2012-12-21
- Reason
- Unintended movement of the system table and/or C arm.
- Root cause
- Software design
- Action
- Siemens 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
- 260 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K940484"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28