Drug recall
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
FDA recall event 83883 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 83883 |
|---|---|
| Recall numbers | Z-0265-2020 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional… |
| Initiation date | Sep 24, 2019 |
| Report date | Nov 27, 2019 |
| Termination date | Jul 8, 2024 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
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: