Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30...
FDA Device Recall #Z-0614-2017 — Class II — July 14, 2016
Recall Summary
| Recall Number | Z-0614-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 14, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merge Healthcare, Inc. |
| Location | Hartland, WI |
| Product Type | Devices |
| Quantity | 29 |
Product Description
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of thirdparty electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data The application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2D and reconstructed 3D radiological images using Webenabled viewers over both local and wide area networks. The application provides workflow integration capabilities for health care enterprises, wherein: ¿ Radiologists can view, annotate, and tag studies as diagnostically Read. ¿ Referring physicians can view patient images and radiologists annotations. ¿ Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.
Reason for Recall
It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray).
Distribution Pattern
Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.
Lot / Code Information
RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31
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-1400-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Ve... | Feb 19, 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-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.