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.
FDA Recall Z-0713-2018 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2017-10-02
Date Terminated2018-09-27
Product Quantity6
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.
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
US Nationwide Distribution in the states of FL, MO, NY, TN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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