Drug recall
SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by…
FDA recall event 73639 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 73639 |
|---|---|
| Recall numbers | Z-1350-2016 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the… |
| Initiation date | Mar 22, 2016 |
| Report date | Apr 20, 2016 |
| Termination date | Aug 7, 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: