CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report

Signa 1.5T TwinSpeed Magnetic Resonance Imaging System recalled

GE Healthcare is recalling Signa 1.5T TwinSpeed Magnetic Resonance Imaging System, distributed nationwide in the US. The recall was initiated on 18 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR

Quantity recalled10 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-0857-2022
FDA event ID: 89720
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 18 Feb 2022
FDA classified: 4 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

18 Feb 2022	Recall initiated by company
4 Apr 2022	Classified by FDA	+45 days
13 Apr 2022	Published in enforcement report	+9 days

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

Reason for recall

There is potential for the images to be flipped left to right.

Product as listed by the FDA

Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

Where it was distributed

Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

There is potential for the images to be flipped left to right.

Which lots are affected?

System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR

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

3 other products · FDA event 89720

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022	CLASS II	Signa Excite 3T recalled by GE Healthcare	GE Healthcare	Other	Nationwide
13 Apr 2022	CLASS II	1.5T Signa Excite HD, 3.0T Signa Excite HD recalled by GE Healthcare	GE Healthcare	Other	Nationwide
13 Apr 2022	CLASS II	1.5T and 3.0T Signa HDx, 1.5T and 3.0T Signa HDxt recalled	GE Healthcare	Other	Nationwide

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