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 | The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport. |
| Product | ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system. |
| Quantity | 271 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Canada, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed. Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E., and United Kingdom. |
| Initiated | 2013-12-22 |
| Classified | 2014-01-24 |
| Terminated | 2015-03-05 |
| Recall number | Z-0825-2014 |
| 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-0825-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67226/
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