GE Healthcare MR system magnets recalled due to cryogen ventilation defect
GE Healthcare is recalling 17,228 MR superconducting magnet components due to a cryogen ventilation system that 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 for a defective cryogen ventilation system on medical imaging equipment. The hazard is potential safety risks from improper ventilation of cryogenic materials, but no injuries or illnesses have been reported, placing this in the High category as a risk-of-harm product where injury has not been documented.
Plain-English summary
GE Healthcare, LLC is recalling approximately 17,228 MR superconducting magnet components used in SIGNA Infinity MR System and SIGNA Infinity MR System with Excite Technology (nuclear magnetic resonance imaging systems). The recalled magnets may have a cryogen ventilation system that does not meet the required venting specifications.
Improperly functioning cryogen ventilation systems could create potential safety risks associated with cryogenic material exposure. The affected systems were distributed nationwide, including Puerto Rico and the Virgin Islands, as well as to government and military facilities, and to institutions in more than 100 countries.
Customers and healthcare facilities with these systems should contact GE Healthcare for instructions on inspection, evaluation, and any necessary corrective measures.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- cryogen-exposure-risk
- ventilation-system-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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