Drug recall
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray…
FDA recall event 83254 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 83254 |
|---|---|
| Recall numbers | Z-1951-2019 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | Additional low dose radiation exposure. |
| Initiation date | Jan 19, 2019 |
| Report date | Jul 24, 2019 |
| 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: