SOMATOM Emotion 16 — Class II medical device recall Z-2473-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-08-08, distributed nationwide. A potential risk of unnecessary radiation exposure due to a software issue
| Recall number | Z-2473-2018 |
|---|---|
| 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 | 2018-02-01 |
| Classified | 2018-07-28 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2020-05-01 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Serial numbers | 32109, 32117, 32118, 32120, 32123, 32124, 32125, 32126, 32127, 32129, 32139, 32141, 32156, 32159, 32169, 32180, 32185, 32187, 32190, 32198, 32200, 32212, 32213, 32215, 32216 and 268 more |
Product
SOMATOM Emotion 16 (10165977)
Reason for recall
A potential risk of unnecessary radiation exposure due to a software issue
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-2473-2018. 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.