Drug recall
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft…
FDA recall event 77249 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 77249 |
|---|---|
| Recall numbers | Z-2591-2017 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis. |
| Initiation date | May 8, 2017 |
| Report date | Jun 21, 2017 |
| Termination date | Aug 8, 2019 |
| 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: