Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
FDA Device Recall #Z-1884-2024 — Class II — April 11, 2024
Recall Summary
| Recall Number | Z-1884-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 11, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | FUJIFILM Healthcare Americas Corporation |
| Location | Lexington, MA |
| Product Type | Devices |
| Quantity | 418 units |
Product Description
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Reason for Recall
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)
Other Recalls from FUJIFILM Healthcare Americas Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1299-2026 | Class II | FDR Visionary Suite; Model Number: CH-200; Ve... | Jan 9, 2026 |
| Z-0044-2026 | Class II | FDR Visionary Suite, CH-200 Model/Version Numb... | Sep 15, 2025 |
| Z-2219-2025 | Class II | ASPRIRE Cristalle Mammography System (cleared u... | Jun 11, 2025 |
| Z-1407-2025 | Class II | Synapse PACS Software Version 7.4.x; Software V... | Feb 11, 2025 |
| Z-1898-2024 | Class II | FDR Visionary Suite - Intended to generate digi... | Apr 11, 2024 |
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.