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 AIR, 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)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
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-0519-2025
- 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-0519-2025 · Source: openFDA enforcement.