Merge Healthcare, Inc. recalls Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the

Recalled March 1, 2017 · FDA recall Z-1246-2017 · Merge Healthcare

Hazard

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) · FDA Class II

Units

1,627 sites potentially have the affected versions

Sold at

Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.

Description

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)

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.

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →