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 | There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system. |
| Product | ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. |
| Quantity | 790 units |
| Distribution | Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal,… |
| Initiated | 2014-06-03 |
| Classified | 2014-07-01 |
| Terminated | 2016-05-25 |
| Recall number | Z-1962-2014 |
| 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-1962-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68529/
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