GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 1,546 magnetic resonance imaging (MRI) machines of several models distributed worldwide, including across the United States except North Dakota and Rhode Island. The recalled devices are the Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w GEM, Discovery MR750w, and Discovery MR750w GEM. These machines have a potential safety issue in which gradient coil electromechanical connections may loosen, causing increased electrical resistance that generates heat during scanning.
The excessive heat from the loose connections can cause materials in the Rear Endbell enclosure to overheat and generate smoke in the scan room, creating a localized hazard. The recall affects specific serial numbers and system IDs of machines distributed across numerous countries. The source document does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localize
Reason for recall: Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localize Distribution: Worldwide Distribution-US (nationwide) except the states of ND and RI, including DC, GU, PR, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA,INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN Quantity: 1,546 (704 US, 842 OUS). Lot/code info: .FMI 60865 (DV Family Gradient Connections) Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W 00000299644MR5 209225VC450 00001026XF5173 209225VC750 00001105XF502C 209SJMR 00000000UA0143 210617HUBMR 00000300706MR9 210MSMTMR 00000000UA0052 21277MR1 00000301045MR1 212989MR1 00000305990MR4 212GE450W 00000301820MR7 214266PCBCMR1 00000302494MR0 214302PDWMR1 00000300930MR5 214590MWMRE3 00001250FMM02W 214645UT3TMR1 00000030251MR2 215ARIA450W 00000304079MR7 217223BHMR 00000303322MR2 217258SBMR1 00000294098MR9 217383CMR5 00000291464MR6 217528MR1 00000000HM0640 217532DVMR 00000299560MR3 217732LMR 00000292843MR0 217788MR3 00001250FMM02E 217876DMH3T 00000307113MR1 217876FMR 00000303450MR1 218828MR 00000000UA0203 225763MR2 00000306130MR6 229228450W 00000123FMM0K4 239VA450MR 00000296369MR2 240215MR 00000302363MR7 240313MR 00000301471MR9 240683MR 00000292634MR3 2486613TMR 00000298535MR6 252436MPMR 00000299171MR9 252482MR450 00001250FMM02T 252NDMR450W 00000296
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.