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Recall Observatory FDA recall evidence

Device 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

Z-1017-2017

December 09, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 75602
Status
Terminated
Classification
Class II
Quantity
1597 (1451 US; 146 OUS)
Official record key
device-enforcement:Z-1017-2017

Official wording

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

Code information: Merge Eye Station software versions: 11.6.0 and prior

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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