ACUSON SC2000 Ultrasound Systems with software version 3 — Class II medical device recall Z-1667-2014
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2014-06-04, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the c
| Recall number | Z-1667-2014 |
|---|---|
| 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 | 2014-04-23 |
| Classified | 2014-05-28 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2015-11-12 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, MD, MI, MN, MO, NC, NH, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AT, AU, CH, DE, FR, GB, ID, IE, IL, IN, IS, IT, JP, KR, MX, NO, NZ, PH, PL, PT, RO, SA, SE, TR |
| Quantity | 257 units |
| Reason classes | software |
| Serial numbers | 400063, 400067, 400108, 400125, 400128, 400142, 400155, 400174, 400176, 400177, 400180, 400200, 400203, 400214, 400218, 400227, 400234, 400247, 400252, 400253, 400263, 400284, 400290, 400297, 400302 and 232 more |
| Model numbers | 10433816 |
Product
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Reason for recall
Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.
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-1667-2014. 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.