Reported Dec 4, 2024 · Ongoing
Discovery MR750w 3.0T, whole body magnetic resonance scanner
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?
- Discovery MR750w 3.0T, whole body magnetic resonance scanner
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 System ID 760724DVMR1, UDI/DI To be provided 2 System ID 214820TS750WMR, UDI/DI To be provided 3 System ID 281333MR2, UDI/DI To be provided 4 00840682103817System ID 82427240081, UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC 5 System ID 82427120136, UDI/DI Not Applicable 6 System ID 82427200092, UDI/DI To be provided 7 System ID 82427250061, UDI/DI To be provided 8 System ID EM0232, UDI/DI Not Applicable - Amount recalled
- 8 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.
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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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