Drug recall
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
FDA recall event 96360 · Class II · FUJIFILM Healthcare Americas Corporation
Key facts
| Event ID | 96360 |
|---|---|
| Recall numbers | Z-1407-2025 |
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
| Product type | Devices |
| Products | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The incorrect computed patient age is showing in VX for patients less than 3 months old. |
| Initiation date | Feb 11, 2025 |
| Report date | Mar 26, 2025 |
| City | Lexington |
| State | MA |
| Country | United States |
| FEI number | 1000513161 |
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: