IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the qu...
FDA Device Recall #Z-2069-2012 — Class II — July 10, 2012
Recall Summary
| Recall Number | Z-2069-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 10, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AGFA Corp. |
| Location | Greenville, SC |
| Product Type | Devices |
| Quantity | 6 |
Product Description
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
Reason for Recall
When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.
Distribution Pattern
Nationwide Distribution including IN, SC, OH, TX
Lot / Code Information
Software Version: RM 2.03 to 2.08, NIV 1.0
Other Recalls from AGFA Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2081-2014 | Class II | AGFA Digital Radiography X-Ray system DX-D 100 ... | Jun 6, 2014 |
| Z-1662-2014 | Class II | IMPAX CV Pediatric Echo Reporting, IMPAX CV Ech... | Apr 30, 2014 |
| Z-0919-2014 | Class II | IMPAX RIS QDOC 5.8 | Jan 8, 2014 |
| Z-0035-2014 | Class II | IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0)... | Sep 19, 2013 |
| Z-1487-2013 | Class II | AGFA Digital Radiography X-Ray System DX-D 100 ... | May 15, 2013 |
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.