Z-1142-2017Class II

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

Name: Z-1142-2017 Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal...
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 "Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health". 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-1142-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Posted: 2017-02-06
Terminated: 2018-06-19
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). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
Product code: HKI Camera, Ophthalmic, Ac-Powered
Reason for recall: Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health.
Root cause tag: software
FDA root cause: Software design
Action: Merge sent an Urgent Medical Device Recall letter on December 9, 2016. The letter was addressed to Office Manager . The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Action by Merge and Actions by Customer. Requested customers 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. For further questions, please call (262) 367- 0700.
Quantity in commerce: 182 capture stations
Distribution: Worldwide Distribution - USA (nationwide) including the states of : CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of Canada and United Kingdom.
Product codes and lots: 136 T1700 Capture Stations 46 T5810 Capture Stations

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1142-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1142-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-06

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)