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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 System see related information
Date Initiated by Firm September 03, 2008
Date Posted January 05, 2009
Recall Status1 Terminated 3 on September 23, 2009
Recall Number Z-0320-2009
Recall Event ID 50077
510(K)Number K040665  
Product Classification Computed tomography x-ray system - Product Code JAK
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.
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 Contact Michael 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
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 in Commerce 168 units
Distribution Nationwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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