ACUSON Maple Diagnostic Ultrasound System — Class II medical device recall Z-1601-2024
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2024-05-01, distributed nationwide. On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measur
| Recall number | Z-1601-2024 |
|---|---|
| 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 | 2024-02-23 |
| Classified | 2024-04-19 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 67 |
| UPC / GTIN / UDI-DI | 04056869995809, 04056869995830 |
| Serial numbers | 700019, 700020, 700022, 700023, 700024, 700025, 700026, 700028, 700029, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700038, 700039, 700040, 700041, 700052, 700053, 700057, 700058 and 42 more |
| Model numbers | 11711750, 11711779 |
Product
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Reason for recall
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
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-1601-2024. 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.