Drug recall
Merge HEMO software.
FDA recall event 74577 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 74577 |
|---|---|
| Recall numbers | Z-2341-2016 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | Merge HEMO software. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 |
| Initiation date | Jul 2, 2012 |
| Report date | Aug 10, 2016 |
| Termination date | Jun 26, 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: