SOMATOM Definition Edge with software version VA48A-SP2 — Class II medical device recall Z-2626-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-08-31, distributed in CA, KY, MI, ND, NE, NY. Due to an internal communication error between the firmware and the software of the components, the planned CT
| Recall number | Z-2626-2016 |
|---|---|
| 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 | 2016-07-13 |
| Classified | 2016-08-23 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-01-24 |
| Distributed | CA, KY, MI, ND, NE, NY |
| Quantity | 4 systems |
| Reason classes | software |
| Serial numbers | 96011, 96020, 96029, 96047 |
| Model numbers | 8098027 |
Product
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Reason for recall
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
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-2626-2016. 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.