Drug recall
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
FDA recall event 98101 · Class II · AGFA Healthcare Corp.
Key facts
| Event ID | 98101 |
|---|---|
| Recall numbers | Z-0923-2026 |
| Recalling firm | AGFA Healthcare Corp. |
| Product type | Devices |
| Products | Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not… |
| Initiation date | Nov 18, 2025 |
| Report date | Dec 31, 2025 |
| City | Greenville |
| State | SC |
| Country | United States |
| FEI number | 3001236302 |
At a glance
- 1–9 Products in this recall
- 1–9 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: