GE MRI Magnet Recall Issued Due to Life-Threatening Injury Risk
Nearly 13,000 superconducting magnets used in MRI machines are being recalled, due to concerns that they may cause serious and potentially life-threatening injuries.
The FDA announced a GE Healthcare MRI system recall on February 18, impacting devices with superconducting magnets.
The action has been categorized as Class I Medical Device Recall, meaning the agency believes that use of the MRI machines could cause severe adverse events or death. It is unclear whether any injuries or deaths have been associated with the recall.
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According to GE, which sent out an “Urgent Medical Device Correction” letter last month, the Magnet Rundown Unit (MRU) may not be connected due to operator error. This can cause a delay in the removal of a ferrous object from the magnet.
If a ferrous object, which includes anything that can be affected by magnets, is in place when the device is activated it could lead to life-threatening injuries. GE warns that the “MRU must be connected to the magnet at all times.
The recall affects all GE Healthcare MRI systems with superconducting magnets, including the 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 Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, and Optima MR450w.
The GE letter and the FDA recall notice include a list of instructions on how to confirm that the MRU is connected to the magnet.
Healthcare professionals with questions can contact their local service representative by calling 262-513-4122.
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