Drug recall
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is…
FDA recall event 74651 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 74651 |
|---|---|
| Recall numbers | Z-2303-2016 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations. |
| Initiation date | Jan 30, 2016 |
| Report date | Aug 10, 2016 |
| Termination date | May 7, 2021 |
| City | Hartland |
| State | WI |
| Country | United States |
| FEI number | 1000116130 |
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: