CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Discovery MR750w 3.0T, whole body magnetic resonance scanner recalled

GE Medical Systems is recalling Discovery MR750w 3.0T, whole body magnetic resonance scanner, distributed nationwide in the US. The recall was initiated on 28 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem ID 760724DVMR1, UDI/DI To be provided; System ID 214820TS750WMR, UDI/DI To be provided; System ID 281333MR2, UDI/DI To be provided; System ID 82427240081, UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC; System ID 82427120136, UDI/DI Not Applicable; System ID 82427200092, UDI/DI To be provided; System ID 82427250061, UDI/DI To be provided; System ID EM0232, UDI/DI Not Applicable

Quantity recalled8 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0517-2025
FDA event ID: 95735
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 28 Oct 2024
FDA classified: 22 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Oct 2024	Recall initiated by company
22 Nov 2024	Classified by FDA	+25 days
4 Dec 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Product as listed by the FDA

Discovery MR750w 3.0T, whole body magnetic resonance scanner

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.

Nationwide

Questions about this recall

Why was it recalled?

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Which lots are affected?

System ID 760724DVMR1, UDI/DI To be provided; System ID 214820TS750WMR, UDI/DI To be provided; System ID 281333MR2, UDI/DI To be provided; System ID 82427240081, UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC; System ID 82427120136, UDI/DI Not Applicable; System ID 82427200092, UDI/DI To be provided; System ID 82427250061, UDI/DI To be provided; System ID EM0232, UDI/DI Not Applicable

Where was it sold?

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 95735

This product is part of a recall event; the main page for the event is Signa Architect AIR, Nuclear Magnetic Resonance Imaging System recalled.

Reported	Class	Recall	Company	Reason	Where
4 Dec 2024	CLASS II	Signa Architect AIR, Nuclear Magnetic Resonance Imaging System recalled	GE Medical Systems	Other	Nationwide
4 Dec 2024	CLASS II	Signa Architect, Nuclear Magnetic Resonance Imaging System recalled	GE Medical Systems	Other	Nationwide
4 Dec 2024	CLASS II	Tomographic Imager Combining Emission Computed Tomography recalled	GE Medical Systems	Other	Nationwide

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