Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic p...
FDA Device Recall #Z-2806-2015 — Class II — June 30, 2015
Recall Summary
| Recall Number | Z-2806-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 30, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fujifilm Medical Systems U.S.A., Inc. |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | multiple |
Product Description
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Reason for Recall
The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.
Distribution Pattern
Nationwide US and Canada
Lot / Code Information
2500.0312.00 and 2500.0312.01
Other Recalls from Fujifilm Medical Systems U.S.A., Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1775-2021 | Class II | Synapse Cardiovascular (Synapse CV). Software... | Apr 30, 2021 |
| Z-1348-2021 | Class II | Synapse PACS - Radiological Image Processing Sy... | Mar 2, 2021 |
| Z-1412-2021 | Class II | ¿TASWako Chip Cassette is part of the Wako ¿TAS... | Feb 18, 2021 |
| Z-0932-2021 | Class III | Wako HDL-C/LDL-C Calibrator - Product Usage: de... | Dec 22, 2020 |
| Z-0918-2021 | Class II | FUJIFILM Synapse PACS Software: versions 7.0.0 ... | Dec 11, 2020 |
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.