Drug recall
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later…
FDA recall event 74773 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 74773 |
|---|---|
| Recall numbers | Z-2379-2016 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. |
| Initiation date | Jan 30, 2016 |
| Report date | Aug 17, 2016 |
| Termination date | Oct 5, 2020 |
| 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: