Reported Dec 4, 2024 · Ongoing
SIGNA Architect, 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, Nuclear Magnetic Resonance Imaging System
- Lot codes and dates
53 of 53 products
Products covered by this recall # Barcodes Product as published 1 00840682147095UDI/DI (01)00840682147095(11)240100(21)PG75M2400278SC, System ID 303467MR2 2 UDI/DI To be provided, System ID 1000005000 3 00840682147095UDI/DI (01)00840682147095(11)220800(21)PG75M2300225SC, System ID 217528MR4 4 00840682147095UDI/DI (01)00840682147095(11)220600(21)PG75M2200130SC, System ID 781SSHMR3 5 UDI/DI To be provided, System ID 301295AMR2 6 UDI/DI To be provided, System ID GON90303794 7 UDI/DI To be provided, System ID 215955HON3T 8 00840682147095UDI/DI (01)00840682147095(11)230600(21)PG75M2300245SC, System ID 806UMCHWMR3T 9 00840682147095UDI/DI (01)00840682147095(11)230800(21)PG75M2300255SC, System ID 703573ARC7 10 00840682122702UDI/DI (01)00840682122702(11)220100(21)PG75A2300133SC, System ID 757953SPMR 11 00840682147095UDI/DI (01)00840682147095(11)231000(21)PG75M2300263SC, System ID 905684MR3T 12 00840682147095UDI/DI (01)00840682147095(11)220800(21)PG75M2200153SC, System ID 82427160355 13 UDI/DI To be provided, System ID 82427100482 14 UDI/DI To be provided, System ID 82427140330 15 UDI/DI To be provided, System ID 82427040333 16 UDI/DI To be provided, System ID 82427200209 17 UDI/DI To be provided, System ID 82427050061 18 UDI/DI To be provided, System ID 82427080138 19 00840682147095UDI/DI (01)00840682147095(11)230400(21)PG75M2300232SC, System ID 82427150128 20 UDI/DI To be provided, System ID 82427200219 - Amount recalled
- 53 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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