GE Healthcare MRI Magnets Recalled for Inadequate Cryogen Ventilation
GE Healthcare is recalling MRI magnets used in SIGNA MR355 and MR360 systems that could have cryogen ventilation systems not meeting venting requirements. These systems were 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 a medical device with a risk-of-harm defect (improper cryogen ventilation system). Per the severity rubric, recalls of risk-of-harm products where injury has not been reported score as High (3).
Plain-English summary
GE Healthcare, LLC is recalling 17,228 MR superconducting magnets used in SIGNA MR355 and SIGNA MR360 magnetic resonance imaging systems. These magnets are components of the MRI systems that were distributed nationwide, including Puerto Rico and the Virgin Islands, as well as internationally to government, military, and commercial facilities across more than 80 countries.
The recall was initiated because the affected magnetic resonance systems could potentially have a cryogen ventilation system that does not meet venting requirements. A cryogen ventilation system that does not meet the applicable venting requirements may pose a potential safety concern related to the operation of the MRI equipment.
This recall affects all systems within the SIGNA MR355 and SIGNA MR360 product lines. The FDA classified this as a Class II recall.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- cryogenic-venting-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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