Drug recall
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table…
FDA recall event 70133 · Class II · GE Healthcare
Key facts
| Event ID | 70133 |
|---|---|
| Recall numbers | Z-0955-2015 |
| Recalling firm | GE Healthcare |
| Product type | Devices |
| Products | The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A required quality control test was not performed during installation associated with the software of the Revolution CT scanner. |
| Initiation date | Nov 12, 2014 |
| Report date | Feb 4, 2015 |
| Termination date | Apr 29, 2015 |
| 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: