Drug recall
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS…
FDA recall event 85793 · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Event ID | 85793 |
|---|---|
| Recall numbers | Z-2471-2020 |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Product type | Devices |
| Products | Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction… |
| Initiation date | May 22, 2020 |
| Report date | Jul 8, 2020 |
| 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: