Drug recall
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging…
FDA recall event 75192 · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Event ID | 75192 |
|---|---|
| Recall numbers | Z-0073-2017 |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Product type | Devices |
| Products | Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Image data for a patient s image may not be correct |
| Initiation date | Sep 15, 2016 |
| Report date | Oct 19, 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: