FDA-Device2017-01-18Class II
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
Merge Healthcare, Inc.
Hazard
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
Sold states
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
Affected count
1597 (1451 US; 146 OUS)
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2017Don't want to check this manually?
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