Class II — Siemens Medical Solutions USA, Inc.
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. |
| Quantity | 257 units |
| Distribution | Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, LS, MD, MI, MN, MO, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI., and the countries of Australia, Austria, Dominican Rep, France, Germany, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Republic Korea, Romania, Ru… |
| Initiated | 2014-04-23 |
| Classified | 2014-05-28 |
| Terminated | 2015-11-12 |
| Recall number | Z-1667-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc. (Z-1667-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68195/
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