AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s D...
FDA Device Recall #Z-2056-2019 — Class II — June 27, 2019
Recall Summary
| Recall Number | Z-2056-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 27, 2019 |
| Status | Terminated |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | Agfa N.V. |
| Location | Mortsel, N/A |
| Product Type | Devices |
| Quantity | 4 |
Product Description
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.
Reason for Recall
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Model/Serial Number/s: 00925, 00945, and 00949, 1136
Other Recalls from Agfa N.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2738-2024 | Class II | DR 800. Digital Radiography X-ray System. | Jul 29, 2024 |
| Z-1462-2024 | Class II | Agfa DX-D 100 system-Digital Radiography mobile... | Feb 23, 2024 |
| Z-2202-2020 | Class II | AGFA Digital Radiography X- Ray system DR 800 w... | Apr 6, 2020 |
| Z-1502-2020 | Class II | AGFA Digital Radiography X- Ray system DR 800 w... | Feb 10, 2020 |
| Z-1034-2019 | Class III | PET Plates Coated Film-MONOMEDBV2S2- Radiograph... | Jan 25, 2019 |
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.