SOMATOM Force — Class II medical device recall Z-1558-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-05-04, distributed nationwide. The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misd
| Recall number | Z-1558-2016 |
|---|---|
| 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 | 2016-04-01 |
| Classified | 2016-04-22 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 37 ctsystems |
| Reason classes | software |
| Serial numbers | 75437, 75439, 75450, 75454, 75458, 75460, 75467, 75475, 75476, 75478, 75481, 75482, 75487, 75493, 75500, 75501, 75510, 75512, 75513, 75514, 75515, 75524, 75526, 75527, 75528 and 12 more |
Product
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
Reason for recall
The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.
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-1558-2016. 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.