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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Force

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  Class 2 Device Recall SOMATOM Force see related information
Date Initiated by Firm April 01, 2016
Date Posted April 22, 2016
Recall Status1 Terminated 3 on April 17, 2017
Recall Number Z-1558-2016
Recall Event ID 73838
510(K)Number K133589  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Force, Computed Tomography x-ray system

intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
Code Information SOMATOM Force Material # 10742326, serial numbers 75550, 75526, 75512, 75567, 75536, 75514, 75563, 75510, 75454, 75540, 75571, 75437, 75500, 75527, 75475, 75535, 75481, 75439, 75450, 75482, 75460, 75493, 75476, 75458, 75528, 75467, 75487, 75478, 75513, 75532, 75555, 75524, 75515, 75559, 75501, 75570, 75576, 75450, 75482, 75528, 75576
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Marlynne Galloway
610-448-6471
Manufacturer Reason
for Recall		 The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.
FDA Determined
Cause 2		 Software design
Action Siemens distributed a Safety Advisory Notice dated April 1, 2016, to affected customers The letter identified the affected product, problem, how to avoid potential risks, how the issue will be resolved. and actions to be taken. Customers were asked to observe the safety notice and comply with the corresponding measures until further notice.
Quantity in Commerce 37 CTsystems
Distribution US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA
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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