SOMATOM Definition Edge — Class II medical device recall Z-0019-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-10-14, distributed nationwide. software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to impr
| Recall number | Z-0019-2016 |
|---|---|
| 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 | 2015-08-14 |
| Classified | 2015-10-05 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 113 total |
| Reason classes | software |
| Serial numbers | 83004, 83014, 83021, 83276, 83277, 83279, 83281 |
| Model numbers | 10590000 |
Product
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Reason for recall
software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
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-0019-2016. 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.