Merge RadSuite software. Radiological image processing system.
FDA Device Recall #Z-2715-2016 — Class II — April 9, 2015
Recall Summary
| Recall Number | Z-2715-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 9, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merge Healthcare, Inc. |
| Location | Hartland, WI |
| Product Type | Devices |
| Quantity | 10 sites have the affected software that is configured with the specific conditions listed in Code Information |
Product Description
Merge RadSuite software. Radiological image processing system.
Reason for Recall
When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
Distribution Pattern
Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
Lot / Code Information
RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if they are configured with all of the following conditions: (1) Must have IPID enabled; (2) Must use IPID morphers (3) Must Define a Defaultvalue in the IPID Morpher; (4) Must use the Aggregating Morpher; (5) Must not set OverwritelfPresent=false; and (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA).
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.