Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1246-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 28, 2016

Date Posted: March 1, 2017

Recall Number: Z-1246-2017

Event ID: 75914

Reason for Recall:

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)

Status: Terminated

Product Quantity: 1,627 sites potentially have the affected versions

Code Information:

Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated