FDA Device recall Z-0519-2025
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System by Ge Medical Systems, citing gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0519-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-28 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
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.
Identifiers
| code_info | UDI/DI (01)00195278283481(11)231214(21)CNARC2300080TJ, System ID 82427110161; UDI/DI (01)00195278283481(11)230519(21)C…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)CNARC2300060T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0519-2025%22
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