ACUSON Maple 1 — Class II medical device recall Z-3217-2024
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2024-10-02, distributed in AL, AR, AZ, CA, CT, FL, GA, GU…. If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec,
| Recall number | Z-3217-2024 |
|---|---|
| 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 | 2024-08-15 |
| Classified | 2024-09-24 |
| Reported by FDA | 2024-10-02 |
| Distributed | AL, AR, AZ, CA, CT, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, VN, ZA |
| Quantity | 321 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869995809, 04056869995830 |
| Model numbers | 11711750, 11711779 |
Product
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
Reason for recall
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
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-3217-2024. 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.