ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual… — Class II medical device recall Z-2321-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-08-05, distributed nationwide. Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ regi
| Recall number | Z-2321-2015 |
|---|---|
| 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 | 2015-07-30 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2017-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, ES, FR, GB, GR, HK, HR, ID, IL, IN, IT, JP, KE, KR, MX, MY, NL, NO, NP, NZ, PH, PL, PT, RO, SA, SE, SG, SI, SK, TR, TW, UA, ZA |
| Quantity | 629 units |
| Serial numbers | 200113, 200140, 200225, 200259, 200291, 200323, 200365, 200641, 200695, 200708, 200734, 200819, 200853, 200974, 201279, 201281, 201387, 201389, 201673, 201937, 201979, 202134, 202137, 202197, 202330 and 475 more |
| Model numbers | 10041461, 10440017, S2000 |
Product
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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 repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.
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-2321-2015. 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.