SOMATOM Sensation 16 Intended to produce cross-sections images of the… — Class II medical device recall Z-1454-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-05-09. to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scan
| Recall number | Z-1454-2018 |
|---|---|
| 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 | 2018-02-15 |
| Classified | 2018-04-30 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2020-04-08 |
| Quantity | 1,301 |
| Reason classes | software |
Product
SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Reason for recall
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
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-1454-2018. 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.