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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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