ACUSON SC2000 Ultrasound System with software versions VB10B and lower — Class II medical device recall Z-2783-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-09-23, distributed nationwide. The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as uniq
| Recall number | Z-2783-2015 |
|---|---|
| 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 | 2015-08-19 |
| Classified | 2015-09-17 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LT, MT, MX, MY, NG, NL, NO, NZ, OM, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SK, SV, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 2,039 devices |
| Serial numbers | 400022, 400023, 400024, 400029, 400048, 400050, 400063, 400065, 400066, 400067, 400069, 400070, 400081, 400084, 400086, 400088, 400090, 400093, 400100, 400102, 400108, 400117, 400118, 400120, 400122 and 475 more |
| Model numbers | 10433816 |
Product
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: 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 ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.
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-2783-2015. 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.