SOMATOM Edge Plus — Class II medical device recall Z-1246-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-05-08, distributed nationwide. Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software i
| Recall number | Z-1246-2019 |
|---|---|
| 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 | 2019-02-14 |
| Classified | 2019-05-02 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2020-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 53 units |
| Reason classes | software |
| Model numbers | 100085, 100087, 100090, 100091, 100092, 100097, 100099, 100107, 100112, 100117, 100129, 100136, 100140, 100143, 100146, 100147, 10267000, 122008, 122009, 122011, 122020, 122022, 122023, 122029, 66649 and 29 more |
Product
SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Reason for recall
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
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-1246-2019. 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.