Merge Healthcare, Inc. recalls Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distribut…

Recall date

December 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1017-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US: Alabama, Alaska, Arizona,Arkansas, California,Colorado,Connecticut,Delaware, District of Columbia, Georgia,Hawaii, Idaho, Illinois,Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland,Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New…

Why it was recalled

This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior