FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ANGIOSTAR Plus X-Ray System, Model number 6379718.
- Recall number
- Z-0134-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ANGIOSTAR Plus X-Ray System, Model number 6379718.
- 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
- 114 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model number 6379718. Serial numbers 1005, 1006, 1011, 1016, 1023, 1033, 1049, 1057, 1059, 1061, 1067, 1069, 1073, 1081, 1082, 1092, 1093, 1095, 1099, 1100, 1101, 1108, 1109, 1113, 1119, 1120, 1121, 1122, 1123, 1127, 1130, 1131, 1134, 1137, 1140, 1144, 1147, 1153, 1155, 1156, 1157, 1159, 1162, 1168, 1169, 1170, 1171, 1172, 1181, 1184, 1186, 1187, 1207, 1210, 1216, 1221, 1223, 1235, 1236, 1241, 1244, 1247, 1248, 1250, 1260, 1261, 1264, 1265, 1267, 1268, 1271, 1272, 1273, 1274, 1275, 1276, 1278, 1284, 1286, 1288, 1290, 1297, 1306, 1308, 1309, 1311, 1313, 1320, 1321, 1335, 1337, 1338, 1345, 1351, 1352, 1354, 1356, 1366, 1367, 1368, 1369, 1371, 1373, 1376, 1378, 1382, 1383, 1385, 1386, 1387, 1388, 1389, 1395, and 9004.
- 510(k) numbers
- ["K884912"]
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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