18L6 HD transducer on the ACUSON S Family ultrasound systems with… — Class II medical device recall Z-1875-2017
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2017-05-03, distributed nationwide. When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound sys
| Recall number | Z-1875-2017 |
|---|---|
| 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 | 2017-03-30 |
| Classified | 2017-04-24 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2019-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BO, BR, CA, CH, CL, CR, CY, CZ, DE, DK, DO, EC, EG, ES, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JP, KR, KW, LB, LU, LV, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, PY, RO, RS, RU, SE, SG, SI, SK, SV, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 2,045 systems |
| Serial numbers | 200113, 200245, 200394, 200408, 200695, 200696, 200706, 200708, 200715, 200935, 201159, 201256, 201916, 202076, 202102, 202551, 202559, 202568, 202569, 202584, 202587, 202600, 202626, 202937, 203212 and 475 more |
| Model numbers | 18L6HD |
Product
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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
When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
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-1875-2017. 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.