[Recalled] Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. — Eye Station images were not importing properly and were importe
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. |
|---|---|
| Brand / manufacturer | Merge Healthcare, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1246-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 28 March 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Merge Healthcare, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.