Z-2754-2017Class II

Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management...

Name: Z-2754-2017 Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management...
Creator: Merge Healthcare, Inc.
Published: 2017-06-13
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2017-06-13 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of 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... on 2017-06-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2754-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-13
Posted: 2017-07-10
Terminated: 2020-09-17
Recalling firm: Merge Healthcare Incorporated
Product: 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 code: NFJ System, Image Management, Ophthalmic
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.
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated the recall by certified letter the week of 06/26/2017. The notice provided the work-around and requested a response.
Quantity in commerce: 18 units
Distribution: FL, IL, CO, MI, CA, NY, ND, OH, CT
Product codes and lots: Version 5.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2754-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2754-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-20

Product code NFJ

K110006Class IIOis Symphony Image Managment SystemOphthalmic Imaging Systems / cleared 2011-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)