FDA Device recall Z-0518-2025
SIGNA Architect, 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, 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-0518-2025 |
| 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, 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)00840682147095(11)240100(21)PG75M2400278SC, System ID 303467MR2; UDI/DI To be provided, System ID 1000005…UDI/DI (01)00840682147095(11)240100(21)PG75M2400278SC, System ID 303467MR2; UDI/DI To be provided, System ID 1000005000; UDI/DI (01)00840682147095(11)220800(21)PG75M2300225SC, System ID 217528MR4; UDI/DI (01)00840682147095(11)220600(21)PG75M2200130SC, System ID 781SSHMR3; UDI/DI To be provided, System ID 301295AMR2; UDI/DI To be provided, System ID GON90303794; UDI/DI To be provided, System ID 215955HON3T; UDI/DI (01)00840682147095(11)230600(21)PG75M2300245SC, System ID 806UMCHWMR3T; UDI/DI (01)00840682147095(11)230800(21)PG75M2300255SC, System ID 703573ARC7; UDI/DI (01)00840682122702(11)220100(21)PG75A2300133SC, System ID 757953SPMR; UDI/DI (01)00840682147095(11)231000(21)PG75M2300263SC, System ID 905684MR3T; UDI/DI (01)00840682147095(11)220800(21)PG75M2200153SC, System ID 82427160355; UDI/DI To be provided, System ID 82427100482; UDI/DI To be provided, System ID 82427140330; UDI/DI To be provided, System ID 82427040333; UDI/DI To be provided, System ID |
|---|
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-0518-2025%22
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