SOMATOM Emotion 6 — Class II medical device recall Z-1644-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-06-03, distributed nationwide. Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan p
| Recall number | Z-1644-2015 |
|---|---|
| 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 | 2015-04-20 |
| Classified | 2015-05-22 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2016-09-01 |
| Distributed | Nationwide (US) |
| Quantity | 75 |
| Reason classes | software |
| Serial numbers | 27230, 27231, 27232, 29338 |
Product
SOMATOM Emotion 6; the intended use of computed tomography is 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 angels or spiral planes taken at different angles.
Reason for recall
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
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-1644-2015. 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.