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U.S. Department of Health and Human Services

Class 2 Device Recall Somatom Sensation 64 XRay System

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 Class 2 Recall
Somatom Sensation 64 XRay System
see related information
Date Posted January 05, 2009
Recall Status1 Terminated on September 23, 2009
Recall Number Z-0321-2009
Recall Event ID 50077
Premarket Notification
510(K) Number
K040665 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Somatom Sensation 64 X-Ray System, Model number 8377520. 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 57084, 57193, 57213, 57261, 57262, 57270, 57272, 57285, and 57298
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 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
DESIGN: 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 9 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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