IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communicati...
FDA Device Recall #Z-2061-2015 — Class II — June 26, 2015
Recall Summary
| Recall Number | Z-2061-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 26, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AGFA Healthcare Corp. |
| Location | Greenville, SC |
| Product Type | Devices |
| Quantity | 2 |
Product Description
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
Reason for Recall
Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.
Distribution Pattern
Distributed in the state of MO.
Lot / Code Information
N/A
Other Recalls from AGFA Healthcare Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0923-2026 | Class II | Brand name: AGFA Digital Radiography X- Ray sys... | Nov 18, 2025 |
| Z-2652-2017 | Class II | IMPAX Cardiovascular The IMPAX CV Reporting mo... | Dec 22, 2016 |
| Z-2735-2017 | Class II | Agfa Healthcare NX 3.0.8950 Imaging Processing ... | Dec 21, 2016 |
| Z-1738-2017 | Class II | DX-D600 - DXD Imaging Package | May 2, 2016 |
| Z-1698-2017 | Class II | AGFA Digital Radiography X-Ray System DX-D100 ... | Jan 20, 2016 |
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.