Drug recall
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of…
FDA recall event 73838 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 73838 |
|---|---|
| Recall numbers | Z-1558-2016 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual… |
| Initiation date | Apr 1, 2016 |
| Report date | May 4, 2016 |
| Termination date | Apr 17, 2017 |
| 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: