Z-0595-2022Class II

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic...

Name: Z-0595-2022 GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic...
Creator: GE Healthcare, LLC
Published: 2021-12-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-12-23 / Open, Classified / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with... on 2021-12-23. FDA classified it as Class II and gives the reason as "The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0595-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-23
Posted: 2022-02-09
Recalling firm: GE Healthcare
Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
Product code: OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Reason for recall: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Quantity in commerce: 17,228 devices total in this field correction
Distribution: 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.
Product codes and lots: All systems.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0595-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0590-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0591-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0592-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0593-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0594-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0595-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0596-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0597-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0598-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0599-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0600-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0601-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0602-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0603-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0604-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0605-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0606-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0607-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0608-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0609-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0610-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0611-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0612-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0613-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0614-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0615-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0616-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0617-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0618-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0619-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0620-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0621-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09

Product code OUO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)