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

Recalled January 18, 2017 · FDA recall Z-1017-2017 · Merge Healthcare

Hazard

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

Units

1597 (1451 US; 146 OUS)

Sold at

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 Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Florida, Tennessee, Wyoming. OUS: Czech Republic Algeria Belgium Brazil Canada Denmark France Germany Greece India Israel Italy Korea, Republic of Luxembourg Netherlands Poland Russian Federation Singapore United Kingdom

Description

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

Product

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

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →