SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
FDA Device Recall #Z-0519-2025 — Class II — October 28, 2024
Recall Summary
| Recall Number | Z-0519-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 28, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 3 units |
Product Description
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Reason for Recall
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Distribution Pattern
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Lot / Code Information
UDI/DI (01)00195278283481(11)231214(21)CNARC2300080TJ, System ID 82427110161; UDI/DI (01)00195278283481(11)230519(21)CNARC2300027TJ, System ID 82427090471; UDI/DI (01)00195278283481(11)231116(21)CNARC2300072TJ, System ID 82427120353; UDI/DI (01)00195278283481(11)230830(21)CNARC2300051TJ, System ID 82427140303; UDI/DI (01)00195278283481(11)230515(21)CNARC2300026TJ, System ID 82427200210; UDI/DI (01)00195278283481(11)230809(21)CNARC2300046TJ, System ID 82427090487; UDI/DI (01)00195278283481(11)230816(21)CNARC2300048TJ, System ID 82427010214; UDI/DI (01)00195278283481(11)230719(21)CNARC2300040TJ, System ID 82427070331; UDI/DI (01)00195278283481(11)230904(21)CNARC2300052TJ, System ID 82427090477; UDI/DI (01)00195278283481(11)231102(21)CNARC2300068TJ, System ID 82427160409; UDI/DI (01)00195278283481(11)230722(21)CNARC2300041TJ, System ID 82427040320; UDI/DI (01)00195278283481(11)231120(21)CNARC2300073TJ, System ID 82427090470; UDI/DI (01)00195278283481(11)231009(21)CNARC2300060TJ, System ID 82427030219; UDI/DI (01)00195278283481(11)240104(21)CNARC2400002TJ, System ID 82427090488; UDI/DI (01)00195278283481(11)231207(21)CNARC2300078TJ, System ID 82427090469; UDI/DI (01)00195278283481(11)230918(21)CNARC2300056TJ, System ID 82427200214; UDI/DI (01)00195278283481(11)240131(21)CNARC2400008TJ, System ID 82427030223; UDI/DI (01)00195278283481(11)240113(21)CNARC2400005TJ, System ID 82427060120; UDI/DI (01)00195278283481(11)231109(21)CNARC2300070TJ, System ID 82427130176; UDI/DI (01)00195278283481(11)230920(21)CNARC2300057TJ, System ID 82427100480; UDI/DI (01)00195278283481(11)231010(21)CNARC2300061TJ, System ID 82427100491; UDI/DI (01)00195278283481(11)230729(21)CNARC2300043TJ, System ID 82427250136; UDI/DI (01)00195278283481(11)240116(21)CNARC2400006TJ, System ID 82427250132; UDI/DI (01)00195278283481(11)240110(21)CNARC2400004TJ, System ID 82427110160; UDI/DI (01)00195278283481(11)231026(21)CNARC2300066TJ, System ID 82427100496; UDI/DI (01)00195278283481(11)231204(21)CNARC2300077TJ, System ID 82427100504; UDI/DI (01)00195278283481(11)230508(21)CNARC2300024TJ, System ID 82427160403; UDI/DI (01)00195278283481(11)231221(21)CNARC2300081TJ, System ID 82427030207; UDI/DI (01)00195278283481(11)240102(21)CNARC2400001TJ, System ID 82427120364; UDI/DI (01)00195278283481(11)231019(21)CNARC2300064TJ, System ID 82427120360; UDI/DI (01)00195278283481(11)240127(21)CNARC2400007TJ, System ID 82427200224; UDI/DI (01)00195278283481(11)231030(21)CNARC2300067TJ, System ID 82427200207; UDI/DI (01)00195278283481(11)231016(21)CNARC2300063TJ, System ID 82427140310; UDI/DI (01)00195278283481(11)230818(21)CNARC2300049TJ, System ID 82427140317; UDI/DI (01)00195278283481(11)230911(21)CNARC2300054TJ, System ID 82427140308; UDI/DI (01)00195278283481(11)230913(21)CNARC2300055TJ, System ID 82427190195
Other Recalls from GE Medical Systems, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2154-2026 | Class II | Revolution Apex, X-ray Computed Tomography, Mod... | Mar 26, 2026 |
| Z-2153-2026 | Class II | Revolution CT ES, X-ray Computed Tomography, Mo... | Mar 26, 2026 |
| Z-2149-2026 | Class II | Revolution Ascend, computed tomography, Model N... | Mar 26, 2026 |
| Z-2151-2026 | Class II | Revolution Apex Elite, X-ray Computed Tomograph... | Mar 26, 2026 |
| Z-2150-2026 | Class II | Revolution CT, x-ray computed tomography, Model... | Mar 26, 2026 |
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.