GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Br
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 9,369 MRI systems worldwide, including 2,937 units in the United States, due to a potential safety issue caused by software versions not being properly maintained at some sites. The affected models include SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRI SYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, and GE 1.5T AND 3.0T SIGNA HDX systems. The recalled systems have been distributed worldwide to numerous countries and U.S. territories.
The recall notice lists specific system identifiers and serial numbers for the affected MRI units. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
Reason for recall: GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites. Distribution: Worldwide Distribution - USA (nationwide) Distribution including PR, GU and DC., and to the countries of: ALBANIA. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONI Quantity: 9,369 (2,937 US, 6,432 OUS). Lot/code info: Mfg Lot or Serial # System ID 00000301098MR0 AL4023MR01 AL4004MR01 AL4009MR01 00000346726YM3 DZ1004MR01 000000HDMR5247 DZ1009MR02 00000267807MR6 DZ1057MR01 00001251FMM01J DZ1006MR01 00000305201MR6 DZ1101MR01 000000HDMR6342 DZ1250MR01 00000002790M24 DZ1396MR01 00000000175M20 DZ1102MR01 00000311125HM9 DZ1072MR01 00000004368M27 DZ1547MR01 00000003534M25 DZ1339MR02 00000005640M28 DZ1339MR01 00001010BD6611 DZ1090MR01 00000015868GQ3 DZ1259MR01 00001011BD667C DZ1005MR01 00000272532MR3 DZ1193MR01 00000005809M29 DZ1598MR01 00000311119HM2 DZ1061MR01 000000HDMR5358 DZ1260MR01 00000290691MR5 DZ1261MR01 00000172500MR1 DZ1033MR02 00000004987M24 DZ1064MR02 00000005787M27 DZ1204MR01 00000009356GQ7 DZ1128MR01 00000306373MR2 DZ1525MR01 00000005637M24 DZ1605MR01 00000099206HM5 DZ1149MR01 00000180852MR6 4406SIGNAMRI 00000002740M29 MRR8513 00000291189YM9 34874SIGNA 00000005153M22 MRR9924 00000147993MR0 132HORIZON 00000305908MR6 MRHM0559 00000305909MR4 MRHM0560 00001011BD6688 16683THDX 00000006310M27 MRR9946 00000301223MR4 2918179MR 00000012619GQ3 4954MR15T 00000011311GQ8 2214SIGNA15 000000000Z001A 221SIGCONT 00000939BD5F5E 2835341HDX 00000014403GQ0 4365SIGNA15 00000012946GQ0 4127SIGNA15 00000014002GQ0 4732SIGNAHDX 00000010316GQ8 4786SIGNA15 00000290572MR7 4867SIGEXC1 00000332881HM2 MRR9196 00000004700M21 MRR9081 00000193354MR8 17SIGNACVI 00000170215MR8 482180SIGNA 00000340717HM8 MRR9358 00000001413M24 2906536HDE 00000332884HM6 MRR9174 00000070159MR9 71727SIGNAGS 00000000471M23 221HORIZONLX 000000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.