Drug recall
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA recall event 75497 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 75497 |
|---|---|
| Recall numbers | Z-0611-2017 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | iConnect Access 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 | Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed. |
| Initiation date | May 25, 2016 |
| Report date | Nov 23, 2016 |
| Termination date | Aug 28, 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: