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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Healthcare SOMATOM Go.Up

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  Class 2 Device Recall Siemens Healthcare SOMATOM Go.Up see related information
Date Initiated by Firm October 02, 2017
Create Date February 24, 2018
Recall Status1 Terminated 3 on September 27, 2018
Recall Number Z-0713-2018
Recall Event ID 79207
510(K)Number K163296  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628

Product Usage:
Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Code Information Serial Numbers: 108054, 108059, 108062, 108069, 108076, 108077
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 table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Siemens sent a Customer Safety Advisory Notice letter date October 2, 2017 to their customers. Customers were instructed not to use the table if there is any unusual noise or vibration and to contact Siemens service organization immediately at 1-800-888-7436. Customers were informed that a service technician will schedule an on site repair.
Quantity in Commerce 6
Distribution US Nationwide Distribution in the states of FL, MO, NY, TN
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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