GE Healthcare MRI Systems Recalled for Potential Ferrous Object Removal Delay
GE Healthcare is recalling MRI systems because a disconnected MRU could delay the removal of ferrous objects, posing a life-threatening injury risk.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, and the source text explicitly states the defect could result in 'life-threatening injuries,' meeting the criteria for a Critical severity score.
Plain-English summary
GE Healthcare is recalling specific MRI systems with superconducting magnets, including the Discovery MR450, MR750, Signa HDx, and various Signa Excite and Infinity models. The recall involves 12,968 units distributed worldwide, with 5,708 units in the United States and 7,260 units outside the US.
The recall is due to a defect where the Magnet Room Unit (MRU) may not be connected to the magnet at certain sites. In emergency situations, a disconnected MRU could delay the removal of a ferrous object from the magnet. This delay potentially results in life-threatening injuries. The MRU must be connected to the magnet at all times to ensure safety.
Affected users should verify that the MRU is properly connected to the magnet. GE Healthcare is the recalling firm for this Class I recall.
The recalled product
- Product
- This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD
- Manufacturer
- GE Healthcare
- Category
- Medical Device — MRI Systems
Distribution
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