Drug recall
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA recall event 90817 · Class II · DICOM Grid, Inc. d/b/a Ambra Health
Key facts
| Event ID | 90817 |
|---|---|
| Recall numbers | Z-1818-2022 |
| Recalling firm | DICOM Grid, Inc. d/b/a Ambra Health |
| Product type | Devices |
| Products | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study. |
| Initiation date | Jun 23, 2022 |
| Report date | Oct 5, 2022 |
| City | New York |
| State | NY |
| 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: