Drug recall
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the…
FDA recall event 86494 · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Event ID | 86494 |
|---|---|
| Recall numbers | Z-0282-2021 |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Product type | Devices |
| Products | Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not… |
| Initiation date | Sep 11, 2020 |
| Report date | Oct 28, 2020 |
| Termination date | Nov 17, 2021 |
| 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: