ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B — Class II medical device recall Z-1584-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-05-13. In certain situations, loss of post exercise images can occur in Stress Echo.
| Recall number | Z-1584-2015 |
|---|---|
| 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 | 2012-07-11 |
| Classified | 2015-05-05 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-05-06 |
| Countries outside the US | AE, AT, AU, BD, BG, CA, CH, CN, CO, DE, DK, EC, EG, ES, FR, GB, HU, IL, IN, IS, IT, JP, KE, KR, KW, MX, MY, NL, PH, PT, SA, SE, SG, TH, TR, TW, VE |
| Quantity | 476 |
| Serial numbers | 400043, 400111, 400116, 400125, 400127, 400140, 400149, 400158, 400159, 400165, 400172, 400178, 400181, 400182, 400187, 400189, 400191, 400192, 400199, 400200, 400205, 400211, 400212, 400213, 400214 and 181 more |
| Model numbers | 10433816, SC2000 |
Product
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
Reason for recall
In certain situations, loss of post exercise images can occur in Stress Echo.
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-1584-2015. 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.