SOMATOM Go — Class II medical device recall Z-0713-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-03-07, distributed nationwide. The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potenti
| Recall number | Z-0713-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2017-10-02 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 6 |
| Serial numbers | 108054, 108059, 108062, 108069, 108076, 108077 |
| Model numbers | 11061628 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0713-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.