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 Echospeed, Signa Ex
Check against the official notice below — it lists the full affected range.
GE Healthcare has issued a correction affecting approximately 12,968 MRI systems worldwide, including 5,708 units in the United States. The affected systems include models Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, and Optima MR36. The issue involves the Magnet Room Unit (MRU) not being connected to the magnet at certain sites. If the MRU becomes disconnected, emergency removal of ferrous objects from the magnet could be delayed, potentially causing life-threatening injuries to patients or personnel.
The MRU must remain connected to the magnet at all times to ensure safe operation. The correction applies to systems distributed across the United States, Puerto Rico, Guam, and numerous countries worldwide. The source record does not specify a remedy or course of action for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
Reason for recall: At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times. Distribution: Worldwide Distribution - US Nationwide in all states in continental USA including DC, PR, GU, and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,K ESTONIA, FIN Quantity: 12,968 (5,708 US, 7,260 OUS). Lot/code info: Mfg Lot or Serial # System ID 00000678440YM9 11 00000439289YM0 8 00000440422YM4 12 00000159739MR2 10 00000340776HM4 MRR9350 00000300911HM5 MRR8614XXX 00000307145MR3 MR307145MR3XXX 00000347253HM7 MRR9546XXX 00000014401YR4 2867718MRHDEXXX 00000227450MR7 333MR3TXXX 00000286146MR6 813EXCITEHDXXX 00000005670GQ5 33575MRI 00000015190GQ2 813EXCITEHD 000000000R5168 PPR88300 00000263679HM3 MEX68913 104203 GPX23300 00000117703YM9 MP917500 00000275290MR5 M2322231 00000144994MR1 F4168003 00000142868MR9 M9886807 00000208223MR8 M4488929 00000834BD4B76 M2865810 00000015769GQ3 M200598201 00000287360MR2 IL1028MR04 00000269936MR1 110010MR03 00000010081GQ8 M4497252 00000265724MR5 80040MRS02 00000213821MR2 00568MRS02 00000274388MR8 M4160077 00000439293YM2 850270280 00000439303YM9 850270057 00000439318YM7 850270174 00000439320YM3 850270022 00000439325YM2 850270186 00000279611MR8 10079MRM74 00000000905M20 PL2130MR01 00000165934MR1 850270060 000000000R6047 55MR2726459 00000284297MR9 83027062101067 00000264745MR1 83027602200145 00000265178MR4 83027202100215 00000270025MR0 83027242101006 00000273677MR5 83027862100276 00000274832MR5 83027202100306 00000286281MR1 83027602101557 00000276493MR4 BA4073MR01 8.70972E+21 706774MRI 412648MR1 412784MR1 317630HDMR 610902HD1 MSK55MR1 317630MR1 LONGWOOD15MR 330535MR2 859226MR 208367LX12 00000014890G08 910272052 00000264618MR0 M4016036 00000015059GQ9 SA1014MR02 00000264740MR2 AZ1003MR01 00000262798MR2 KW1013MR02 00000274935MR6 SY2037MR01 352344MR ALLIANCESIG437 409
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.