GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall
GE Healthcare is recalling Discovery MR750w 3.0T MRI systems due to cryogen ventilation systems that may not meet FDA venting requirements. Approximately 17,228 devices were 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: This is an FDA Class II recall addressing a potential equipment safety defect in a safety-critical medical device. The cryogen ventilation system is essential to equipment operation, making this a risk-of-harm product. No injuries have been reported, but the defect itself represents a potential hazard, meeting the criteria for High severity.
Plain-English summary
GE Healthcare, LLC is recalling GE Healthcare Discovery MR750w 3.0T System magnetic resonance imaging devices. The superconducting magnets used in these systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Approximately 17,228 devices were distributed nationwide, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. The systems were also distributed internationally to over 100 countries.
Affected healthcare facilities should contact GE Healthcare immediately for information on whether their equipment is affected and to arrange for inspection and correction of the ventilation system.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- ventilation-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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