Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Why it was recalled
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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 82427200209; UDI/DI To be provided, System ID 82427050061; UDI/DI To be provided, System ID 82427080138; UDI/DI (01)00840682147095(11)230400(21)PG75M2300232SC, System ID 82427150128; UDI/DI To be provided, System ID 82427200219; UDI/DI To be provided, System ID 82427080142; UDI/DI To be provided, System ID 82427230234; UDI/DI (01)00840682147095(11)231000(21)PG75M2300266SC, System ID 82427100499; UDI/DI To be provided, System ID 82427160405; UDI/DI To be provided, System ID 82427160407; UDI/DI (01)00840682147095(11)230600(21)PG75M2300247SC, System ID 82427160390; UDI/DI To be provided, System ID 82427160408; UDI/DI To be provided, System ID 82427160402; UDI/DI To be provided, System ID 82427120372; UDI/DI To be provided, System ID 82427120357; UDI/DI To be provided, System ID 82427120351; UDI/DI (01)00840682147095(11)230700(21)PG75M2300253SC, System ID 82427150130; UDI/DI (01)00840682147095(11)240100(21)PG75M2400276SC, System ID 82427030222; UDI/DI (01)00195278283481(11)231113(21)CNARC2300071TJ, System ID 82427030218; UDI/DI (01)00840682147095(11)230600(21)PG75M2300248SC, System ID 83027009451123; UDI/DI (01)00840682147095(11)240200(21)ANTAT2400005TJ, System ID MR00169; UDI/DI (01)00840682147095(11)240200(21)ANTAT2400004TJ, System ID MR00168; UDI/DI (01)00840682147095(11)240100(21)ANTAT2400001TJ, System ID MR00185; UDI/DI (01)00840682122702(11)180223(21)PG75A1800019MR, System ID 850270540; UDI/DI To be provided, System ID 850270791; UDI/DI To be provided, System ID LV4001MR03; UDI/DI (01)00840682147095(11)230600(21)PG75M2300246SC, System ID MRUA2408; UDI/DI To be provided, System ID P00434MR01; UDI/DI To be provided, System ID RF3138MR01; UDI/DI To be provided, System ID RU1838MR04; UDI/DI To be provided, System ID RF3580MR01; UDI/DI To be provided, System ID SA1058MR05; UDI/DI (01)00840682147095(11)221100(21)PG75M2200180SC, System ID FEG88320; UDI/DI (01)00840682147095(11)230800(21)PG75M2300256SC, System ID DE492A99; UDI/DI To be provided, System ID NEV439249; UDI/DI To be provided, System ID 853270212; UDI/DI To be provided, System ID 853270202; UDI/DI (01)00840682147095(11)230300(21)PG75M2300227SC, System ID 853270223
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Recall record
- Recalling firm
- GE Medical Systems, LLC
- Product type
- Devices
- Recall number
- Z-0518-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Waukesha, WI
- Recall initiated
- 2024-10-28
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0518-2025 · Source: openFDA enforcement.