Drug recall
SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the…
FDA recall event 75812 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 75812 |
|---|---|
| Recall numbers | Z-0742-2017, Z-0743-2017, Z-0744-2017 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane…, SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial…, SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software update that provides software and firmware bug-fixes to improve system performance |
| Initiation date | Nov 15, 2016 |
| Report date | Dec 21, 2016 |
| Termination date | Apr 27, 2018 |
| 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: