FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.
- Recall number
- Z-0138-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.
- 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
- 66 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- 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.
- 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
- 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