FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: NEUROSTAR TOP X-Ray System, Model numbers 6258425 and 6379668.
- Recall number
- Z-0148-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- NEUROSTAR TOP X-Ray System, Model numbers 6258425 and 6379668.
- 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
- 57 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model number 6258425 - Serial numbers: 1001, 1004, 1008, 1010, 1012, 1015, 1018, 1019, 1021, 1026, and 1029. Model number 6379668 - Serial numbers: 1109, 1111, 1119, 1121, 1122, 1123, 1126, 1127, 1128, 1130, 1134, 1135, 1137, 1140, 1141, 1142, 1143, 1144, 1147, 1149, 1151, 1152, 1154, 1155, 1156, 1159, 1163, 1165, 1171, 1173, 1174, 1175, 1176, 1179, 1180, 1181, 1185, 1190, 1192, 1194, 1195, 1196, 1201, 1205, 1208, and 1209.
- 510(k) numbers
- ["K930635"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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