ACUSON Redwood 2 — Class II medical device recall Z-2582-2023
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2023-09-20, distributed nationwide. If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultras
| Recall number | Z-2582-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Issaquah, WA, United States |
| Recall initiated | 2023-07-13 |
| Classified | 2023-09-13 |
| Reported by FDA | 2023-09-20 |
| Distributed | Nationwide (US) |
| Quantity | 796 |
| UPC / GTIN / UDI-DI | 04056869251264 |
| Model numbers | 11503314 |
Product
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Reason for recall
If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.
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-2582-2023. 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.