GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 756 Discovery MR750w 3.0T, Discovery MR450 1.5T, Discovery MR750 3.0T, and Optima MR450w 1.5T magnetic resonance imaging systems distributed worldwide, including across the United States and territories. The systems have a safety issue where displayed SAR (specific absorption rate) values during head or neck scans may be lower than the actual SAR in the head as measured through SAR modeling.
According to SAR modeling predictions, the actual SAR in the head could exceed the IEC60601-2-33 international safety limit of 3.2 W/kg for some scans on affected devices. The recall source does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Reason for recall: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans. Distribution: Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAK Quantity: 756 Lot/code info: 00000302690MR3 HCIMR1805 00000290502MR4 MR129030 00000291489MR3 415723SHMR10 00000294472MR6 650723SSMR1 00000290704MR6 650723SSMR2 00000289310MR5 HSSMR750 00000289961MR5 SINAI750MR 00000290457MR1 608263MR6 00000290050MR4 281276MR750 00000290659MR2 610740MR3 00000290202MR1 415723CHMR2 290957MR0 608HERIMR 00000290636MR0 MR129034 00000290137MR9 650723NCMR1 00000289309MR7 650723NCMR2 00000291397MR8 517353DVMR 00000291363MR0 616391DVMR 00000291980MR1 704384DVMR 00000292367MR0 INSIGHTMR3228 00000292471MR0 804675VA3T 00000288408MR8 608WAISMR 00000292634MR3 2486613TMR 00000288907MR9 MR129035 00000292431MR4 541CMRIMR 00000290773MR1 415L3TMR2 00000291877MR9 415L3TMR1 00000291185MR7 MSK65MR1 00000292528MR7 608WIMRMR2 00000291244MR2 MSK65MR2 00000293338MR0 206CH750MR 00000291464MR6 217528MR1 00000292843MR0 217788MR3 00000294556MR6 540665MR3T 00000293261MR4 415OI3TMR 00000293015MR4 910907WAMR1 00000292678MR0 919684MR5 00000293561MR7 405752I3T 00000293874MR4 HSSGMR750 00000294018MR7 903525MR750 00000000000641 434UVAMR 00000294057MR5 281274MR1 00000294576MR4 602830MR3 00000294698MR6 812485MR3 00000294665MR5 480768MR2 00000294718MR2 715838MR3T 00000295112MR7 801377MR3 00000295024MR4 207945MR750 00000295111MR9 703391MR2 00000294953MR5 7579533T 00000295802MR3 269DVMR 00000295228MR1 6036503T 00000296046MR6 309683MNMR750 00000295904MR7 281477MR2 00000295506MR0 858822HDMR1 00000296014MR4 816932DVMR 00000296640MR6 617726MR1A2 00000296512MR7 916LST3TMR 00000296461MR7 MR129037 00000294999MR8 MSK68MR
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.