Recall archive / FDA device enforcement
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System — FDA record Z-0519-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 28, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
- Reason
- Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Classification
- Class II
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 3 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0519-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 4, 2024
- Recall initiation date
- Oct 28, 2024
- Center classification date
- Nov 22, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.