GE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall
GE Healthcare is recalling 17,228 MR Vectra MRI systems because the cryogenic ventilation system may not meet required venting specifications.
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 of a medical device with a theoretical hazard (improper cryogenic ventilation) that has not yet resulted in reported illnesses or injuries. Per the severity rubric, recalls with theoretical hazards and no reported incidents score at most 3. The medical device application justifies a High classification.
Plain-English summary
GE Healthcare is recalling 17,228 MR superconducting magnets that are components of the GE Healthcare MR Vectra System, a nuclear magnetic resonance imaging (MRI) device. The systems contain cryogenic ventilation systems that may not meet required venting specifications.
The recall applies to all MR Vectra systems in use. This ventilation system deficiency has been classified by the FDA as a Class II recall due to the potential safety risk.
The affected systems were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands, as well as to government and military installations. GE Healthcare also distributed these systems internationally to healthcare facilities in numerous countries across Europe, Asia, Africa, the Middle East, and Latin America.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Equipment
- Hazard
- ventilation-defect
- cryogenic-hazard
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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