GE Healthcare, Discovery MR750w
Check against the official notice below — it lists the full affected range.
GE Healthcare has identified a potential safety hazard with the Discovery MR750w magnetic resonance imaging system. A small area on the patient bore surface—the part normally accessible to patients—can become warm enough to cause a serious burn if a patient touches it without proper padding. As of the recall notice, no injuries have been reported to GE Healthcare related to this issue.
The affected equipment includes 471 systems worldwide: 184 in the United States across multiple states and territories, and 287 internationally distributed across numerous countries. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.
Reason for recall: GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue. Distribution: US: AK, AZ, CA, COM, CT , DC, FL, GA, GU, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH,OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY. OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bermuda Brazil Bulgaria Canada China Egypt France Germany Hungary India Indonesia Ireland Italy Japan Kazakhstan Korea (Republic of) Kuwait Lebanon Mexico Netherlands New Zea Quantity: 471 (184 US; 287 OUS) Lot/code info: Mfg Lot or Serial # System ID 00001250FMM03D 9075653T 00001308FMM00B 602863MR Missing_SN_GON4205067 480342MR3 00001134FMM10E 928348MR 00001140FMM0FX RADNETMR597 N/A 530CHI750W N/A 858824MR1 00000000UA0083 408356MR1 00001204FMM058 RADNETMR599 00000000UA0262 949760MR3 00000308185MR8 510449MR750W 00000000UA0075 619543HDMR4 00000000UA0118 858622HDMR1 00001204FMM052 415CB3TW 00001309FMM08B RADNETMR613 00001307FMM09Y 415UCBHMR3 1-4G33-86 805739MR3 310871MR9 310264MR2 309905MR8 RADNETMR621 00001204FMM04G 559734VIMR1 000005373011-3 RADNETMR598 N/A 720848MR4 N/A 720848MR3 311108MR5 303492MR 00001118FMM0WE 303604MR2 00001309FMM09E 720854MR 00000000UA0472 719365MR Missing_SN_GON4077136 303837MR2 309815MR9 970624MR1 310950MR1 860446MR750W 00001251FMM00R 202966MR3TW Missing_SN_GON4231312 561955MR1 00001309FMM097 386FNSBMR3T 00001308FMM042 954355MR750W 1309FMM09F 904483MR3T 00000000UA0465 305665MR750W 00001204FMM057 305461MR1 00001140FMM0FG 407SMSLMR1 00001147FMM0E5 386FHPCMR3T 00001223FMM08M 561844MR1 N/A 706787750DV 00001236FMM04Y 912819MR 00001301FMM043 671NAVYMR 00001234FMM0KL 671FHPMR750W 310330MR6 808HRAEMR750W 00001204FMM055 808545MR 00001250FMM035 808YMMR 00000306104MR1 808873MR750W 1-4GFG-928 319335MR2 310776MR0 773665SJMR2 PG75W1600017MR 312702MR750 00001250FMM02E 217876DMH3T N/A 847316MR3T 00000305089MR5 708346MR3 00000307816MR9 708346MR4 310973MR3 309655IMRI 00001309FMM094 309655MR750W N/A 815968MR 00001203FMM0VP 815395MR2 00000306062MR1 847872ZMR2 00000309665MR8 317887MR3 0000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.