Siemens Medical Solutions USA, Inc: 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.

Agency Publication Date: February 24, 2018

Affected Products

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 c

Serial Numbers: 108054, 108059, 108062, 108069, 108076, 108077

Product: SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 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

Serial Number: 106115

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79207

Status: Resolved

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 2 products (6; 1)

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Sources: FDA iRES · Raw API Response

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Affected Products

Serial Numbers: 108054, 108059, 108062, 108069, 108076, 108077

Serial Number: 106115