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 issue results in inaccurate 3D image may result in ablation in wrong location. |
| Product | Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes. |
| Quantity | 26 units |
| Distribution | Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey. |
| Initiated | 2013-07-10 |
| Classified | 2013-10-23 |
| Terminated | 2013-11-25 |
| Recall number | Z-0052-2014 |
| 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-0052-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65812/
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