FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.
- Recall number
- Z-0166-2010
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.
- Status
- Terminated
- Initiated
- 2009-07-01
- Posted
- 2009-11-10
- Terminated
- 2010-01-12
- Reason
- The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.
- 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
- 107 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Model number 5294009. Serial numbers: 1001, 1004, 1017, 1019, 1024, 1029, 1033, 1038, 1040, 1042, 1048, 1055, 1056, 1060, 1062, 1066, 1067, 1070, 1075, 1083, 1085, 1088, 1090, 1092, 1093, 1094, 1101, 1102, 1103, 1104, 1105, 1107, 1108, 1113, 1115, 1116, 1117, 1119, 1123, 1126, 1127, 1130, 1134, 1138, 1143, 1144, 1146, 1147, 1148, 1149, 1152, 1157, 1158, 1160, 1166, 1167, 1173, 1177, 1178, 1180, 1184, 1186, 1192, 1196, 1207, 1213, 1214, 1216, 1217, 1226, 1229, 1231, 1233, 1234, 1235, 1236, 1237, 1238, 1240, 1245, 1247, 1248, 1250, 1256, 1262, 1263, 1265, 1266, 1281, 1283, 1289, 1290, 1292, 1293, 1294, 1296, 1297, 1300, 1302, 1303, 1305, 1308, 1312, 1314, 1319, 1321, and 1322.
- 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