CLASS II ONGOING Device recall · Reported 16 Feb 2022 · FDA Enforcement Report

MR superconducting magnets, a component of GE Healthcare 5T recalled

GE Healthcare is recalling GE Healthcare MR superconducting magnets, a component of GE Healthcare 5T Signa HDe MR, distributed nationwide in the US. The recall was initiated on 23 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll systems.

Quantity recalled17,228 devices total in this field correction

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-0609-2022
FDA event ID: 89376
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 23 Dec 2021
FDA classified: 9 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

23 Dec 2021	Recall initiated by company
9 Feb 2022	Classified by FDA	+48 days
16 Feb 2022	Published in enforcement report	+7 days

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

Reason for recall

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.

Where it was distributed

Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign distribution was made to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaidjan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Republic of Congo, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, Equatorial Guinea, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrhyzstan, Latvia, Lebanon, Libyan Arabic Jamahiriya, Lithuania, Luxembourg, Macedonia, Madagascar, Malaysia, Mali, Malta, Mauritania, Mexico, Republic of Moldova, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Nordic-HQ, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Zambia, and Zimbabwe.

Nationwide Georgia Puerto Rico

Questions about this recall

Is MR superconducting magnets, a component of GE Healthcare 5T Signa HDe MR System, nuclear recalled?

Yes. GE Healthcare recalled MR superconducting magnets, a component of GE Healthcare 5T Signa HDe MR System, nuclear on 23 Dec 2021. The recall is Class II and its status is Ongoing. Recall number Z-0609-2022.

Why was it recalled?

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Which lots are affected?

All systems.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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