Not Applicable · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2024-06-14	Z-2466-2024	Class II	Open, Classified	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.Distribution: Worldwide distribution.	123 units	clearance family
2021-12-23	Z-0595-2022	Class II	Open, Classified	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.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.	17,228 devices total in this field correction	clearance family
2017-05-11	Z-3022-2017	Class II	Terminated	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.Distribution: 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	68 units in total	code info di
2017-05-11	Z-3023-2017	Class II	Terminated	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.Distribution: 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	68 units in total	code info di
2017-05-11	Z-3024-2017	Class II	Terminated	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.Distribution: 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	68 units in total	code info di
2017-05-11	Z-3025-2017	Class II	Terminated	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.Distribution: 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	68 units in total	code info di
2017-05-11	Z-3027-2017	Class II	Terminated	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.Distribution: 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	68 units in total	code info di
2017-05-11	Z-3028-2017	Class II	Terminated	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.Distribution: 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	68 units in total	code info di
2017-05-11	Z-3029-2017	Class II	Terminated	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.Distribution: 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	68 units in total	code info di
2017-05-11	Z-3026-2017	Class II	Terminated	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.Distribution: 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	68 units in total	code info di

Showing 1–10 of 12

Regulatory clearances

510(k)K142098Substantially equivalent (SESE) · 2014-11-24clearance family

Predicate lineage

K142098

Cited as predicate by: K150331, K161574, K163619, K183014

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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