CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report

Signa Vibrant Nuclear Magnetic Resonance Imaging System recalled

GE Healthcare is recalling Signa Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, distributed nationwide in the US. The recall was initiated on 23 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg. Lot or Serial # System ID 22D-4-0868 901BMHCRITMR HDGOC1900010SC 209521SGMR HDGOC1900015SC 4577711MR11 002776WHF 954916MR1 022D-4-1175 808243MR 857 LONGWOOD30MR2 00000290815MR0 508580BMR3 002801WHF 734246MR 002930WHF 845279MR 00000269040MR2 412749MR1 022D-4-1125 801RIVMR2 HDGOC1900003SC 206386SMR H05114 4815915MR11 00000277443MR8 304526SMR1 To be provided GON4796599 To be provided 424881MR01 To be provided 083027829345912 To be provided 083027862100408

Quantity recalled62 (30 US, 32 OUS) total 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-0877-2020
FDA event ID: 84655
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 23 Dec 2019
FDA classified: 28 Jan 2020
Reported: 5 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Imaging Equipment

Timeline

23 Dec 2019	Recall initiated by company
28 Jan 2020	Classified by FDA	+36 days
5 Feb 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

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

Product as listed by the FDA

SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - 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 and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Mfg. Lot or Serial # System ID 22D-4-0868 901BMHCRITMR HDGOC1900010SC 209521SGMR HDGOC1900015SC 4577711MR11 002776WHF 954916MR1 022D-4-1175 808243MR 857 LONGWOOD30MR2 00000290815MR0 508580BMR3 002801WHF 734246MR 002930WHF 845279MR 00000269040MR2 412749MR1 022D-4-1125 801RIVMR2 HDGOC1900003SC 206386SMR H05114 4815915MR11 00000277443MR8 304526SMR1 To be provided GON4796599 To be provided 424881MR01 To be provided 083027829345912 To be provided 083027862100408

Where was it sold?

Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

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 84655

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

Reported	Class	Recall	Company	Reason	Where
5 Feb 2020	CLASS II	Signa Architect Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Labeling Errors	Nationwide
5 Feb 2020	CLASS II	Signa Pioneer Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Labeling Errors	Nationwide
5 Feb 2020	CLASS II	Signa Premier Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Labeling Errors	Nationwide

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