GE Healthcare MR Superconducting Magnets Recalled for Ventilation Defect
GE Healthcare recalled 17,228 superconducting magnets, a component of SIGNA 1.5T MR systems, due to a cryogen ventilation system that may not meet venting requirements. Systems are 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: FDA Class II recall of medical imaging equipment with a potential safety defect in the cryogenic ventilation system. No injuries or illnesses reported; this constitutes a risk-of-harm situation per the severity rubric.
Plain-English summary
GE Healthcare is recalling 17,228 superconducting magnets that are components of GE SIGNA 1.5T TwinSpeed magnetic resonance imaging systems. The affected systems have a cryogen ventilation system that does not meet required venting specifications.
The recall affects systems distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as government and military installations. International distribution spans more than 100 countries and territories.
No injuries or illnesses have been reported.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance 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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