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U.S. Department of Health and Human Services

Class 2 Device Recall Somatom Sensation 40 XRay System

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 Class 2 Device Recall Somatom Sensation 40 XRay Systemsee related information
Date Initiated by FirmSeptember 03, 2008
Date PostedJanuary 05, 2009
Recall Status1 Terminated 3 on September 23, 2009
Recall NumberZ-0320-2009
Recall Event ID 50077
510(K)NumberK040665 
Product Classification Computed tomography x-ray system - Product Code JAK
ProductSomatom 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactMichael Van Ryn
610-448-4500
Manufacturer Reason
for Recall		software error - does not allow protocol to properly synchronize with ECG triggers
FDA Determined
Cause 2		Software design
ActionThe 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 in Commerce168 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
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