RecallDepth

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.

This recall has been terminated (originally issued July 10, 2017).

Company
Merge Healthcare, Inc.
Recall Initiated
June 13, 2017
Posted
July 10, 2017
Terminated
September 17, 2020
Recall Number
Z-2754-2017
Quantity
18 units
Firm Location
Hartland, WI
Official Source
View on FDA website ↗

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.

Distribution

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

Lot / Code Info

Version 5.2

Root Cause

Software design

Action Taken

The firm initiated the recall by certified letter the week of 06/26/2017. The notice provided the work-around and requested a response.

More recalls by Merge Healthcare, Inc.

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