FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: 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
- Recall number
- Z-1017-2017
- Recalling firm
- Merge Healthcare, Inc.
- 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
- Status
- Terminated
- Initiated
- 2016-12-09
- Posted
- not on file
- Terminated
- 2021-03-24
- Reason
- This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
- Root cause
- Software design
- Action
- Consignees were sent on 12/9/2016 a Merge "Urgent Medical Device Recall" letter. The letter was addressed to Office Manager and Recall # 216-078. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested consignees to provide response to the "Response to this Notification is Required". If the product was further distributed advised consignees to notify them at once. For questions send an e-mail to recall@merge.com. E-mails to be sent to consignees on 12/19/2016.
- Quantity
- 1597 (1451 US; 146 OUS)
- Distribution
- 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
- Lot, serial or model codes
- Merge Eye Station software versions: 11.6.0 and prior
- 510(k) numbers
- ["K913929"]
- PMA numbers
- not on file
- Product code
- HKI
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28