Drug recall
Synapse PACS - Version 7.1.000
FDA recall event 94090 · Class II · FUJIFILM Healthcare Americas Corporation
Key facts
| Event ID | 94090 |
|---|---|
| Recall numbers | Z-1268-2024, Z-1269-2024, Z-1270-2024, Z-1271-2024, Z-1272-2024, Z-1273-2024 |
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
| Product type | Devices |
| Products | Synapse PACS - Version 7.1.000, Synapse PACS - Version 7.1.000US, Synapse PACS - Version 7.2.000, Synapse PACS - Version 7.2.100, Synapse PACS - Version 7.2.200 and 1 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. |
| Initiation date | Jan 10, 2024 |
| Report date | Mar 13, 2024 |
| 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: