# FDA recall Z-0713-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2017-10-02.

## 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.

## 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.

## Distribution

US Nationwide Distribution in the states of FL, MO, NY, TN

## Key facts

- **Recall number:** Z-0713-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-02
- **Report date:** 2018-03-07
- **Termination date:** 2018-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0713-2018

## Citation

> AI Analytics. FDA recall Z-0713-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0713-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*