CLASS II Device recall · Reported 27 Oct 2021 · FDA Enforcement Report

Signa Creator, Signa Explorer nuclear magnetic resonance recalled

GE Healthcare is recalling Signa Creator, Signa Explorer nuclear magnetic resonance imaging system, distributed in 19 states. The recall was initiated on 26 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version DV29.1

Quantity recalled6 devices

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-0137-2022
FDA event ID: 88665
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 26 Aug 2021
FDA classified: 16 Oct 2021
Reported: 27 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

26 Aug 2021	Recall initiated by company
16 Oct 2021	Classified by FDA	+51 days
27 Oct 2021	Published in enforcement report	+11 days

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

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Product as listed by the FDA

SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

Where it was distributed

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

Arizona California Florida Georgia Illinois Louisiana Massachusetts Maryland Minnesota North Carolina New Hampshire New Jersey New York Ohio Oklahoma Puerto Rico Texas Virginia Washington

Questions about this recall

Why was it recalled?

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Which lots are affected?

Software version DV29.1

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

9 other products · FDA event 88665

This product is part of a recall event; the main page for the event is Signa Pioneer nuclear magnetic resonance imaging system recalled.

Reported	Class	Recall	Company	Reason	Where
27 Oct 2021	CLASS II	Signa Pioneer nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states
27 Oct 2021	CLASS II	Optima MR450w 1.5T nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states
27 Oct 2021	CLASS II	1.5T Signa HDxt MR System nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states
27 Oct 2021	CLASS II	Signa Architect nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states
27 Oct 2021	CLASS II	Discovery MR750w 3.0T nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states
27 Oct 2021	CLASS II	Signa Voyager nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states
27 Oct 2021	CLASS II	Signa Artist nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states
27 Oct 2021	CLASS II	Discovery MR750 3.0T nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states
27 Oct 2021	CLASS II	Signa Premier nuclear magnetic resonance imaging system recalled	GE Healthcare	Other	19 states

More recalls from GE Healthcare

All 512

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