GE Healthcare MRI systems recalled for cryogenic ventilation defect
GE Healthcare MRI systems may have cryogenic ventilation systems that do not meet venting requirements. The recall affects 17,228 devices distributed nationwide and globally. Healthcare facilities should contact GE Healthcare for corrective actions.
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 medical device recall without reported illnesses or injuries. Improper cryogenic ventilation systems pose a risk of harm to patients and healthcare personnel, meeting the rubric criterion for High severity as a risk-of-harm product without yet-reported injury.
Plain-English summary
GE Healthcare MRI superconducting magnets, which are components of the SIGNA Horizon Cx System and related models (SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), are being recalled. These magnets may be part of systems with cryogenic ventilation systems that do not meet required venting standards.
The recall involves 17,228 devices distributed nationwide, including Puerto Rico and the Virgin Islands. Affected systems were also distributed to government and military facilities and to healthcare providers in approximately 80 countries.
Healthcare facilities and providers with affected systems should contact GE Healthcare, LLC for information about corrective actions and guidance on continued safe operation of their equipment.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- cryogenic-ventilation
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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