GE Healthcare MRI Systems with Potentially Non-Compliant Cryogen Ventilation Systems
GE Healthcare has recalled approximately 17,228 MRI systems due to cryogen ventilation systems that may not meet required venting standards. The issue affects systems distributed nationwide and internationally.
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 involving a safety-critical cryogen ventilation system that may not meet regulatory venting requirements. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High severity score.
Plain-English summary
GE Healthcare, LLC has issued a recall of the MR superconducting magnets, a critical component of the GE Healthcare SIGNA MR380 System, a nuclear magnetic resonance imaging system. The recall impacts approximately 17,228 devices worldwide.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Proper ventilation of cryogenic systems is essential for safe operation of MRI equipment.
The affected systems were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands. The recall also affects systems distributed to government and military facilities within the United States. Additionally, systems were distributed internationally to over 90 countries worldwide.
Healthcare facilities and medical clinics with affected systems should contact GE Healthcare for further information regarding the recall and any corrective actions needed to ensure safe continued use of their equipment.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- ventilation-defect
- asphyxiation-risk
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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