Z-0166-2010

Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray...

Name: Z-0166-2010 Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray...
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-07-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-07-01 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System on 2009-07-01. The reason FDA records is "The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0166-2010
Status: Terminated
Initiated: 2009-07-01
Posted: 2009-11-10
Terminated: 2010-01-12
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.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: 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 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: 107 units
Distribution: Nationwide Distribution.
Product codes and lots: 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.

Product code IZI

K884912Class IIAngiostarSiemens Medical Solutions USA, Inc. / cleared 1989-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)