CLASS II Device recall · Reported 23 Aug 2017 · FDA Enforcement Report

1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant recalled

GE Medical Systems is recalling 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant, distributed nationwide in the US. The recall was initiated on 11 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378

Quantity recalled68 units in 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-3028-2017
FDA event ID: 77488
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 11 May 2017
FDA classified: 11 Aug 2017
Reported: 23 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

11 May 2017	Recall initiated by company
11 Aug 2017	Classified by FDA	+92 days
23 Aug 2017	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

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

Product as listed by the FDA

1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the 1.5T Signa HDx family and 3.0T Signa HDx family reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Where it was distributed

US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI

Nationwide Alaska California Colorado Connecticut Delaware Florida Iowa Illinois Indiana Kansas Kentucky Louisiana Maryland Missouri North Dakota Nebraska New Jersey New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

Which lots are affected?

Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378

Where was it sold?

US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI

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

8 other products · FDA event 77488

This product is part of a recall event; the main page for the event is Optima MR450 1.5T recalled by GE Medical Systems.

Reported	Class	Recall	Company	Reason	Where
23 Aug 2017	CLASS II	Optima MR450 1.5T recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Optima MR750 3.0T recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Optima MR450w 1.5T recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt recalled	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Signa Creator, Signa ExplorerProduct Usage recalled	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Discovery MR750 3.0T recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Signa PET/MR (K163619, K142098) recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
23 Aug 2017	CLASS II	Brivo MR355, Optima MR360 recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide

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