Events

Recall of Device Recall Merge Eye Care PACS Viewer 5.2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merge Healthcare, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77627
  • Event Risk Class
    Class 2
  • Event Number
    Z-2754-2017
  • Event Initiated Date
    2017-06-13
  • Event Date Posted
    2017-07-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156932
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image management, ophthalmic - Product Code NFJ
  • Reason
    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.
  • 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.

Device

Device Recall Merge Eye Care PACS Viewer 5.2
  • Model / Serial
    Version 5.2
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, IL, CO, MI, CA, NY, ND, OH, CT
  • 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.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.