Drug recall
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
FDA recall event 87079 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 87079 |
|---|---|
| Recall numbers | Z-0771-2021 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| Reason for recall | System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan |
| Initiation date | Nov 24, 2020 |
| Report date | Jan 20, 2021 |
| Termination date | Feb 6, 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: