Drug recall
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system…
FDA recall event 75034 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 75034 |
|---|---|
| Recall numbers | Z-2865-2016 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Patient information in the header is only found on the first page of the report and not on the subsequent pages. |
| Initiation date | Jan 30, 2016 |
| Report date | Sep 28, 2016 |
| Termination date | Dec 15, 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: