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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 July 03, 2019
Create Date August 14, 2019
Recall Status1 Open3, Classified
Recall Number Z-2274-2019
Recall Event ID 83377
510(K)Number K133589  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
Code Information Serial Numbers: 75765 75949 94851 75984 76019 75789 75512 75770 75600 75994 76046 75768 75974 75867 75510 75535 75820 75754 75755 75993 75916 75971 75893 75944 75540 76027 75980 75571 75848 75953 75885 75500 75973 75850 75527 75728 75939 75923 83819 76057 75450 75760 75806 75808 75476 75588 75931 75900 75981 75906 75602 75964 75804 75837 75787 75743 76010 76041 75936 75959 75905 75942 75941 75805 75884 76006 75919 76003 75913 76050 76016 75524 75778 75501 75570 75769 75983 75849 76000 75999 75976 76008 75616 75750 76001 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-219-4834
Manufacturer Reason
for Recall		 Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
FDA Determined
Cause 2		 Software design
Action Siemens has initiated a Customer Safety Advisory Notice (CSAN) to all affected customers via CT035/19/S. Customers with valid email addresses were emailed a copy of the CSAN on 07/03/2019 via Adobe Mega Sign. The CSAN were distributed to the remaining customers without a valid email address via certified mail on 07/12/2019. Additionally, a solution to eliminate the root cause of this problem (application of software update VB20) will be distributed to all affected customers free of charge. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented.
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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