Drug recall
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging…
FDA recall event 96208 · Class II · GE Medical Systems, LLC
Key facts
| Event ID | 96208 |
|---|---|
| Recall numbers | Z-1043-2025, Z-1044-2025, Z-1045-2025, Z-1046-2025 |
| Recalling firm | GE Medical Systems, LLC |
| Product type | Devices |
| Products | Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system., Discovery XR656 HD. X-Ray imaging system., Discovery XR656HD. X-Ray imaging system., Optima XR646 HD. X-Ray imaging system. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all… |
| Initiation date | Jan 28, 2025 |
| Report date | Feb 12, 2025 |
| 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: