Drug recall
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images…
FDA recall event 66917 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 66917 |
|---|---|
| Recall numbers | Z-0840-2014 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another… |
| Initiation date | Oct 9, 2013 |
| Report date | Feb 5, 2014 |
| Termination date | Jun 19, 2014 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
At a glance
- 1–9 Products in this recall
- 10–99 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: