ACUSON S 1000 — Class II medical device recall Z-2314-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-08-05, distributed nationwide. Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measureme
| Recall number | Z-2314-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Mountain View, CA, United States |
| Recall initiated | 2015-06-25 |
| Classified | 2015-07-29 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2017-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, LB, MA, MX, MY, NL, NO, NP, NZ, PE, PH, PL, PT, RO, RS, SA, SE, SG, SK, SV, TH, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 1,789 units |
| Serial numbers | 200001, 200164, 200181, 200201, 200225, 200245, 200276, 200278, 200291, 200313, 200327, 200331, 200365, 200392, 200393, 200394, 200398, 200523, 200532, 200533, 200534, 200549, 200550, 200624, 200641 and 475 more |
| Model numbers | 10041461, 10440017, 2000, S2000 |
Product
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Reason for recall
Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
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-2314-2015. 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.