ACUSON SC2000 Ultrasound System — Class II medical device recall Z-0824-2014
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2014-02-05, distributed nationwide. The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to
| Recall number | Z-0824-2014 |
|---|---|
| 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 | 2013-12-22 |
| Classified | 2014-01-24 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BR, CA, CH, CN, DE, DK, EC, EG, ES, FI, FR, GB, IL, IN, IS, IT, JP, KR, KW, MX, MY, NL, NO, OM, PH, PL, QA, RO, SA, SE, SG, SK, TH, TR, TW, VE, ZA |
| Quantity | 843 active |
| Serial numbers | 400022, 400023, 400024, 400029, 400048, 400050, 400063, 400065, 400066, 400067, 400068, 400069, 400070, 400081, 400083, 400084, 400085, 400086, 400088, 400090, 400091, 400092, 400093, 400100, 400102 and 475 more |
| Model numbers | 10433816 |
Product
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
Reason for recall
The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.
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-0824-2014. 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.