GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect
GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths mentioned in the source text. The hazard is described as theoretical (systems "could potentially" have the defect) rather than confirmed harm. Per the severity rubric, recalls with no reported harm and theoretical hazards are rated as Moderate or lower.
Plain-English summary
GE Healthcare, LLC is recalling GE Healthcare MR superconducting magnets, a component of the GE Healthcare Orthone (1.0T MSK Extreme) System, a nuclear magnetic resonance imaging system. Approximately 17,228 devices are included in this field correction.
The superconducting magnets could potentially have a cryogen ventilation system that does not meet the required venting specifications. This defect could affect the proper functioning of the cryogen ventilation system.
The affected systems were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. International distribution was made to numerous countries worldwide.
Facilities with affected systems should contact GE Healthcare for instructions on inspection, remediation, or replacement of the affected magnets.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI System
- Hazard
- ventilation-system-defect
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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