GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect
GE Healthcare MR superconducting magnets in SIGNA MRI systems may have cryogen ventilation systems that do not meet safety venting requirements. Approximately 17,228 systems are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a critical safety system (cryogenic ventilation) that does not meet design requirements. While no injuries or incidents have been reported, improper ventilation of cryogenic materials poses potential risk to personnel in healthcare settings.
Plain-English summary
GE Healthcare is recalling superconducting magnets used in SIGNA Excite 1.5T and 3.0T magnetic resonance imaging systems. The cryogen ventilation system in these magnets may not meet venting requirements, creating a potential safety hazard.
The affected systems were distributed nationwide in the United States, Puerto Rico, and the Virgin Islands, as well as to government and military facilities. International distribution extended to over 90 countries. Approximately 17,228 systems are involved in this field correction.
Healthcare facilities with affected MRI systems should verify their system identification and contact GE Healthcare for information about corrective actions. The recall is classified as a Class II device recall by the U.S. Food and Drug Administration.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- ventilation-defect
- cryogenic-safety
- equipment-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All systems.
Distribution
Distributed nationwide across the United States.
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