Drug recall
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical…
FDA recall event 76471 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 76471 |
|---|---|
| Recall numbers | Z-1385-2017 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The software is not adding the correct tomo image. |
| Initiation date | Apr 8, 2016 |
| Report date | Mar 8, 2017 |
| Termination date | Mar 6, 2017 |
| 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: