GE Healthcare MRI superconducting magnets recalled for improper cryogen venting
GE Healthcare has recalled SIGNA Pioneer MRI systems due to potential cryogen ventilation defects that do not meet safety requirements. Approximately 17,228 devices are affected 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: This Class II recall concerns a potential defect in the cryogen ventilation system of a medical device component. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as a risk-of-harm product without documented injury, warranting a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling MR superconducting magnets used in the SIGNA Pioneer System, a nuclear magnetic resonance (MRI) imaging system. The recall affects approximately 17,228 devices and is classified as a Class II recall by the FDA.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. These systems are found in the superconducting magnets component of the SIGNA Pioneer System.
The affected devices were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. International distribution extended to more than 100 countries.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- improper-cryogen-venting
- equipment-safety-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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