Z-1017-2017Class II

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

Name: Z-1017-2017 Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager...
Creator: Merge Healthcare, Inc.
Published: 2016-12-09
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-12-09 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS)... on 2016-12-09. FDA classified it as Class II and gives the reason as "This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1017-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Posted: 2017-01-12
Terminated: 2021-03-24
Recalling firm: Merge Healthcare Incorporated
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
Product code: HKI Camera, Ophthalmic, Ac-Powered
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.
Root cause tag: software
FDA 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 [email protected]. E-mails to be sent to consignees on 12/19/2016.
Quantity in commerce: 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
Product codes and lots: Merge Eye Station software versions: 11.6.0 and prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1017-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1017-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-12

Product code HKI

K913929Class IIDfc-1024 & Dfc-512 Digital Imaging SystemOphthalmic Imaging Systems / cleared 1991-11-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)