ACUSON SC2000 Ultrasound System — Class II medical device recall Z-1056-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-02-11, distributed in GA. The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel can
| Recall number | Z-1056-2015 |
|---|---|
| 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 | 2015-01-12 |
| Classified | 2015-02-05 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2015-11-12 |
| Distributed | GA |
| Countries outside the US | AE, AT, AU, CA, CN, DE, EC, ES, FI, FR, GB, IE, IL, IN, IQ, IT, JP, KR, LT, MX, NG, PH, PT, RS, SA, SE, TR, TW, ZA |
| Quantity | 230 |
| Reason classes | device malfunction |
| Serial numbers | 401100, 401400 |
| Model numbers | 10433816 |
Product
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. 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
The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.
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-1056-2015. 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.