Reported Dec 4, 2024 · Ongoing
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3200 N Grandview Blvd · Waukesha, WI · 53188-1693
Is this the product you have?
- SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
- Lot codes and dates
36 of 36 products
Products covered by this recall # Barcodes Product as published 1 00195278283481UDI/DI (01)00195278283481(11)231214(21)CNARC2300080TJ, System ID 82427110161 2 00195278283481UDI/DI (01)00195278283481(11)230519(21)CNARC2300027TJ, System ID 82427090471 3 00195278283481UDI/DI (01)00195278283481(11)231116(21)CNARC2300072TJ, System ID 82427120353 4 00195278283481UDI/DI (01)00195278283481(11)230830(21)CNARC2300051TJ, System ID 82427140303 5 00195278283481UDI/DI (01)00195278283481(11)230515(21)CNARC2300026TJ, System ID 82427200210 6 00195278283481UDI/DI (01)00195278283481(11)230809(21)CNARC2300046TJ, System ID 82427090487 7 00195278283481UDI/DI (01)00195278283481(11)230816(21)CNARC2300048TJ, System ID 82427010214 8 00195278283481UDI/DI (01)00195278283481(11)230719(21)CNARC2300040TJ, System ID 82427070331 9 00195278283481UDI/DI (01)00195278283481(11)230904(21)CNARC2300052TJ, System ID 82427090477 10 00195278283481UDI/DI (01)00195278283481(11)231102(21)CNARC2300068TJ, System ID 82427160409 11 00195278283481UDI/DI (01)00195278283481(11)230722(21)CNARC2300041TJ, System ID 82427040320 12 00195278283481UDI/DI (01)00195278283481(11)231120(21)CNARC2300073TJ, System ID 82427090470 13 00195278283481UDI/DI (01)00195278283481(11)231009(21)CNARC2300060TJ, System ID 82427030219 14 00195278283481UDI/DI (01)00195278283481(11)240104(21)CNARC2400002TJ, System ID 82427090488 15 00195278283481UDI/DI (01)00195278283481(11)231207(21)CNARC2300078TJ, System ID 82427090469 16 00195278283481UDI/DI (01)00195278283481(11)230918(21)CNARC2300056TJ, System ID 82427200214 17 00195278283481UDI/DI (01)00195278283481(11)240131(21)CNARC2400008TJ, System ID 82427030223 18 00195278283481UDI/DI (01)00195278283481(11)240113(21)CNARC2400005TJ, System ID 82427060120 19 00195278283481UDI/DI (01)00195278283481(11)231109(21)CNARC2300070TJ, System ID 82427130176 20 00195278283481UDI/DI (01)00195278283481(11)230920(21)CNARC2300057TJ, System ID 82427100480 - Amount recalled
- 3 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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