Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1017-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 9, 2016

Date Posted: January 18, 2017

Recall Number: Z-1017-2017

Event ID: 75602

Reason for Recall:

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

Status: Terminated

Product Quantity: 1597 (1451 US; 146 OUS)

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

Voluntary or Mandated:

Voluntary: Firm initiated