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The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imagin...

FDA Device Recall #Z-0939-2019 — Class II — December 20, 2018

Recall Summary

Recall Number Z-0939-2019
Classification Class II — Moderate risk
Date Initiated December 20, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Merge Healthcare, Inc.
Location Hartland, WI
Product Type Devices
Quantity 1,252 Units

Product Description

The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.

Reason for Recall

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).

Distribution Pattern

Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, , Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West , Virginia, Wisconsin. International distribution to Algeria, Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Israel, Netherlands, Puerto Rico, United Kingdom.

Lot / Code Information

UDI: 00842000100140. 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Other Recalls from Merge Healthcare, Inc.

Recall # Classification Product Date
Z-2518-2025 Class II Merge Hemo, Model RCSV2, Model/Catalog Number 9... Aug 11, 2025
Z-1399-2025 Class II VERICIS, Merge Cardio, Model/Catalog Number: Ve... Feb 19, 2025
Z-1402-2025 Class II Merge Cardio, Model/Catalog Number: Version 12.... Feb 19, 2025
Z-1400-2025 Class II VERICIS, Merge Cardio, Model/Catalog Number: Ve... Feb 19, 2025
Z-1398-2025 Class II VERICIS, Merge Cardio, Model/Catalog Number: Ve... Feb 19, 2025

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Merge Healthcare, Inc. Recalls by Firm Recall Reasons Device Safety Stats