—#74665

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K040665
Affected lot / code info: 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.

Why it was recalled

software error - does not allow protocol to properly synchronize with ECG triggers

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2008-09-03
Posted by FDA: 2009-01-05
Terminated: 2009-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74665. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.