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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- Manufacturer
- GE Healthcare
- Category
- Medical Device — MRI Systems
Distribution
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