FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
- Recall number
- Z-0320-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
- Status
- Terminated
- Initiated
- 2008-09-03
- Posted
- 2009-01-05
- Terminated
- 2009-09-23
- Reason
- software error - does not allow protocol to properly synchronize with ECG triggers
- Root cause
- Software design
- Action
- The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500.
- Quantity
- 168 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial numbers 54016, 54027, 54031, 54033, 54035,54045, 54049, 54050, 54051, 54052, 54056, 54060, 54062, 54064, 54074, 54075, 54085, 54094, 54104, 54108, 54119, 54127, 54129, 54137, 54140, 54144, 54146, 54148, 54154, 54156, 54170, 54172, 54175, 54180, 54186, 54193, 54194, 54198, 54203, 54204, 54219, 54220, 54221, 54222, 54229, 54233, 54248, 54250, 54253, 54254, 54258, 54271, 54306, 54307, 54309 54319, 54325, 54419, 54677, 54684, 54690, 55019, 55022, 55023, 55024, 55035, 55041, 55043, 55047, 55061, 55063,55066, 55070, 55071, 55075, 55080, 55081, 55082, 55090, 55093, 55097, 55100, 55102, 55103, 55110, 55111, 55113, 55115, 55116, 55121, 55122, 55123, 55138, 55141, 55144, 55149, 55156, 55158, 55166, 55172, 55179, 55182, 55183, 55189, 55194, 55207, 55209, 55211, 55230, 55246, 55249, 55250, 55260, 55261, 55265, 55269, 55270, 55274, 55275, 55279, 55283, 55284, 55285, 55286, 55295, 55308, 55309, 55310, 55311, 55316, 55319, 55322, 55325, 55332, 55333, 55336, 55344, 55353, 55357, 55360, 55363, 55369, 55373, 55377, 55385, 55389, 55393, 55398, 55404, 55405, 55406, 55407, 55415, 55416, 55417, 55422, 55423, 55424, 55426, 55428, 55429, 55434, 55440, 55448, 55454, 55455, 55457, 55458, 55466, and 55467.
- 510(k) numbers
- ["K040665"]
- PMA numbers
- not on file
- Product code
- JAK
- 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