Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1681-2017)

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

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: April 5, 2017

Recall Number: Z-1681-2017

Event ID: 76309

Reason for Recall:

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

Status: Terminated

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

Code Information:

All versions of Eye Care PACS, Eye Station, and ESIU.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated