Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, manag...
FDA Device Recall #Z-2754-2017 — Class II — June 13, 2017
Recall Summary
| Recall Number | Z-2754-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 13, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merge Healthcare, Inc. |
| Location | Hartland, WI |
| Product Type | Devices |
| Quantity | 18 units |
Product Description
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
Reason for Recall
When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.
Distribution Pattern
FL, IL, CO, MI, CA, NY, ND, OH, CT
Lot / Code Information
Version 5.2
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 healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.