Drug recall
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient…
FDA recall event 75564 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 75564 |
|---|---|
| Recall numbers | Z-0665-2017 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The application may crash during the cath lab procedure. |
| Initiation date | Apr 30, 2014 |
| Report date | Dec 7, 2016 |
| Termination date | Dec 23, 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: