FDA Device recall Z-2582-2023
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
- FDA Device
- Class II
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 by Siemens Medical Solutions Usa, citing 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 me….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2582-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-13 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Reason
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.
Identifiers
| code_info | UDI-DI: 04056869251264. Systems with software version prefix VA20. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2582-2023%22
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