GE Healthcare MRI Superconducting Magnets: Cryogen Ventilation System Defect
GE Healthcare is recalling 17,228 MRI systems because the cryogen ventilation system may not meet venting requirements. The company is providing field corrections to ensure proper ventilation.
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 with a safety-related deficiency in cryogen ventilation systems. Although no illnesses or injuries have been reported, improper ventilation of cryogenic systems poses a risk of harm to patients and medical personnel.
Plain-English summary
GE Healthcare has recalled 17,228 superconducting magnet components used in Brivo MR355 and Optima MR360 MRI systems. The cryogen ventilation systems may not meet the required venting specifications.
The affected systems were distributed nationwide across the United States, including Puerto Rico and the Virgin Islands, and internationally to numerous countries. Healthcare facilities operating these systems should contact GE Healthcare for verification and corrective action information.
GE Healthcare is providing field corrections to address this issue and ensure that cryogen ventilation systems meet safety requirements. Facilities should work with the manufacturer to implement appropriate corrective measures.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- cryogenic-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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