Merge Eye Station 11.6.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842000100140), received between Dec 11, 2018 and Dec 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of Data” (1 report).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K913929); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 20, 2018Class IITerminated

   Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground).

   Z-0939-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2018Loss of Data; Loss of Data

  MERGE EYE STATION IS INTENDED TO BE USED IN CONJUNCTION WITH EXISTING OPHTHALMIC FUNDUS CAMERAS TO TAKE IMAGES OF THE EYE, PERFORM FLUORESCEIN ANGIOGRAPHY, RED FREE, COLOR AND ICG STILL-IMAGE PHOTOGRAPHY AS WELL AS VIDEO IMAGING. ON 11/14/2018, MERGE HEALTHCARE RECEIVED INFORMATION FROM AN ACCOUNT THAT A SYSTEM IS FREEZING UP DURING FA IMAGING. (FLUORESCEIN ANGIOGRAM). THE CUSTOMER HAS TO EXIT OUT OF THE SOFTWARE, RE-OPEN IT, AND RE-LOAD THE PATIENT'S RECORD ONCE THE FLUORESCEIN DYE HAS BEEN INJECTED INTO THE PATIENT, AFFECTING THE ARTERIAL VENOUS FLUSH TIMES. ADDITIONALLY, THE IMAGES ARE VERY BLURRY AND NECESSARY DETAILS FOR DIAGNOSIS AND TREATMENT ARE DIFFICULT TO SEE. SUPPORT HAS SCHEDULED A SITE VISIT IN ORDER TO TROUBLE SHOOT AND CORRECT THE ISSUE. THIS ISSUE IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM RELATED TO THE INABILITY OF THE EYE CARE PROFESSIONAL TO OBTAIN THE NECESSARY INFORMATION FOR PROCEDURES. NO PATIENT HARM OCCURRED AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8149883 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K913929. One submission often covers many models, so check the product and lot details in each record.

• Z-1017-2017 · Dec 9, 2016 · Terminated
  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 an
• Z-1142-2017 · Dec 9, 2016 · Terminated
  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 13
• Z-1681-2017 · Apr 4, 2016 · Terminated
  Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
• Z-1828-2017 · Apr 4, 2016 · Terminated
  Merge Eye Station and Merge Eye Care PACS.
• Z-1246-2017 · Mar 28, 2016 · Terminated
  Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.