ACUSON SC2000 Ultrasound Systems between software versions VA16A and… — Class II medical device recall Z-1959-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-07-08. When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where so
| Recall number | Z-1959-2015 |
|---|---|
| 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 | 2015-05-29 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-03-09 |
| Countries outside the US | AE, AT, AU, BD, BG, BO, BR, CA, CH, CN, CO, CZ, DE, EC, EG, ES, FI, FR, GB, HU, IE, IL, IN, IS, IT, JP, KE, KR, KW, LT, MX, MY, NG, NL, OM, PH, PL, PT, QA, RO, RS, SA, SE, SK, TH, TR, TW, VE, ZA |
| Quantity | 573 devices |
| Serial numbers | 400043, 400065, 400069, 400087, 400111, 400113, 400115, 400117, 400123, 400127, 400137, 400140, 400149, 400150, 400152, 400153, 400159, 400160, 400161, 400165, 400166, 400170, 400175, 400181, 400184 and 475 more |
| Model numbers | 10433816, SC2000 |
Product
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. 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. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Reason for recall
When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
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-1959-2015. 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.