Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2754-2017)

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 PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.

Product Classification:

Class II

Date Initiated: June 13, 2017

Date Posted: July 26, 2017

Recall Number: Z-2754-2017

Event ID: 77627

Reason for Recall:

When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.

Status: Terminated

Product Quantity: 18 units

Code Information:

Version 5.2

Distribution Pattern:

FL, IL, CO, MI, CA, NY, ND, OH, CT

Voluntary or Mandated:

Voluntary: Firm initiated