GE Healthcare MR superconducting magnets recall
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
Why was GE Healthcare MR superconducting magnets recalled?
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All systems.
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 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.
- Recall date
- February 16, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)