Drug recall
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA recall event 76258 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 76258 |
|---|---|
| Recall numbers | Z-1180-2017 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment. |
| Initiation date | Nov 17, 2015 |
| Report date | Feb 15, 2017 |
| Termination date | Feb 10, 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: