Merge Healthcare, Inc. recalls Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU

Recalled April 5, 2017 · FDA recall Z-1681-2017 · Merge Healthcare

Hazard

The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. · FDA Class II

Units

1,627 sites potentially have the affected software

Sold at

Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.

Description

The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.

Product

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

Manufacturer(s)

Merge Healthcare, Inc.

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