Z-0138-2009

Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383

Name: Z-0138-2009 Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-08-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-08-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383 on 2008-08-11. The reason FDA records is "Unintended movement of the system table and/or C arm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0138-2009
Status: Terminated
Initiated: 2008-08-11
Posted: 2008-11-04
Terminated: 2012-12-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Unintended movement of the system table and/or C arm.
Root cause tag: software
FDA 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 in commerce: 66 units
Distribution: Nationwide.
Product codes and lots: Model number 6379767 - Serial numbers: 2002, 2004, 2005, 2011, 2012, 2015, 2016, 2017, 2018, 2022, 2025, 2026, 2033, 2042, 2045, 2055, 2058, 2059, 2063, 2066, 2070, 2072, 2078, 2083, 2089, 2092, 2093, 2094, 2096, 2097, 2098, 2099, and 2101. Model number 6258383: Serial numbers: 1014, 1015, 1034, 1044, 1045, 1050, 1054, 1061, 1067, 1073, 1090, 1091, 1099, 1101, 1102, 1103, 1109, 1115, 1122, 1126, 1128, 1132, 1133, 1137, 1138, 1141, 1142, 1143, 1147, 1152, 1156, 1157, and 1162.

Product code IZI

K940484Class IICoroskop Hi-P Angiographic X-Ray SystemSiemens Medical Solutions USA, Inc. / cleared 1994-04-19

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)