ACUSON SC2000 volume imaging ultrasound systems at software versions… — Class II medical device recall Z-1581-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-05-13, distributed nationwide. In some cases, the system is unable to capture a clip or image during a routine scan.
| Recall number | Z-1581-2015 |
|---|---|
| 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 | 2012-05-11 |
| Classified | 2015-05-05 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CH, CN, CO, CZ, DE, ES, FI, FR, GB, IN, JP, KE, KR, KW, MX, NO, OM, PL, RO, SA, SE, SG, SK, TH, TR, TW |
| Quantity | 186 devices |
| Serial numbers | 400023, 400083, 400084, 400092, 400126, 400139, 400168, 400223, 400225, 400230, 400236, 400265, 400270, 400308, 400318, 400404, 400458, 400459, 400460, 400461, 400462, 400463, 400466, 400467, 400470 and 32 more |
| Model numbers | 10433816 |
Product
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. 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. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;
Reason for recall
In some cases, the system is unable to capture a clip or image during a routine scan.
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-1581-2015. 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.