Drug recall
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions…
FDA recall event 65812 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 65812 |
|---|---|
| Recall numbers | Z-0052-2014 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software issue results in inaccurate 3D image may result in ablation in wrong location. |
| Initiation date | Jul 10, 2013 |
| Report date | Oct 30, 2013 |
| Termination date | Nov 25, 2013 |
| City | Mountain View |
| State | CA |
| Country | United States |
| FEI number | 3009498591 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: