Drug recall
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm…
FDA recall event 74372 · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Event ID | 74372 |
|---|---|
| Recall numbers | Z-2043-2016 |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Product type | Devices |
| Products | Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead |
| Initiation date | May 10, 2016 |
| Report date | Jun 29, 2016 |
| Termination date | Feb 20, 2019 |
| City | Stamford |
| State | CT |
| Country | United States |
| FEI number | 2443168 |
At a glance
- 1–9 Products in this recall
- None 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: