Drug recall
Intelerad InteleShare software, with ProViewer component
FDA recall event 97993 · Class II · DICOM Grid, Inc.
Key facts
| Event ID | 97993 |
|---|---|
| Recall numbers | Z-0941-2026 |
| Recalling firm | DICOM Grid, Inc. |
| Product type | Devices |
| Products | Intelerad InteleShare software, with ProViewer component |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar… |
| Initiation date | Nov 18, 2025 |
| Report date | Dec 24, 2025 |
| City | Raleigh |
| State | NC |
| Country | United States |
| FEI number | 3008776294 |
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: