SOMATOM Perspective 16 — Class II medical device recall Z-2475-2018
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-2475-2018 |
|---|---|
| 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 | 87522, 87525, 87526, 87528, 87532, 87533, 87534, 87535, 87537, 87539, 87540, 87541, 87542, 87544, 87546, 87548, 87549, 87552, 87553, 87554, 87555, 87556, 87558, 87559, 87560 and 13 more |
| Model numbers | 10891666 |
Product
SOMATOM Perspective 16 (Model 10891666)
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-2475-2018. 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.