CLASS II Device recall · Reported 28 Oct 2020 · FDA Enforcement Report

System, Nuclear Magnetic Resonance Imaging recalled by GE Healthcare

GE Healthcare is recalling System, Nuclear Magnetic Resonance Imaging, distributed nationwide in the US. The recall was initiated on 8 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 5741000-23 and 5396469

Quantity recalled30 devices total

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-0128-2021
FDA event ID: 86452
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 8 Sep 2020
FDA classified: 20 Oct 2020
Reported: 28 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

8 Sep 2020	Recall initiated by company
20 Oct 2020	Classified by FDA	+42 days
28 Oct 2020	Published in enforcement report	+8 days

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

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Product as listed by the FDA

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

Nationwide Florida Kentucky North Carolina New Jersey New Mexico New York Puerto Rico Texas Utah Washington

Questions about this recall

Why was it recalled?

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Which lots are affected?

Model: 5741000-23 and 5396469

Where was it sold?

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

4 other products · FDA event 86452

This product is part of a recall event; the main page for the event is System, Nuclear Magnetic Resonance Imaging recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
28 Oct 2020	CLASS II	System, Nuclear Magnetic Resonance Imaging recalled by GE Healthcare	GE Healthcare	Other	Nationwide
28 Oct 2020	CLASS II	System, Nuclear Magnetic Resonance Imaging recalled by GE Healthcare	GE Healthcare	Other	Nationwide
28 Oct 2020	CLASS II	System, Nuclear Magnetic Resonance Imaging recalled by GE Healthcare	GE Healthcare	Other	Nationwide
28 Oct 2020	CLASS II	Tomographic Imager Combining Emission Computed Tomography recalled	GE Healthcare	Other	Nationwide

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