Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling approximately 3,849 GE Magnetic Resonance System units used for diagnostic imaging worldwide, including distribution across all U.S. states and multiple countries. The recall was initiated because an incorrect software version may have been loaded on these systems. The affected equipment includes various MRI models operating at different field strengths, ranging from 0.2T to 1.5T, with multiple model numbers and system identifications listed.
The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Possible incorrect software version loaded.
Reason for recall: Possible incorrect software version loaded. Distribution: Worldwide Distribution - US Nationwide AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus Quantity: 3,849 Lot/code info: Product Name Sold Under System ID Model # *WH*MR SIGNA 1.0T HORIZON 5.X HISPE GPX23300 2108050 0.2T SIGNA PROFILE 2761614-1 5179427 0.7T OPENSPEED EXITE PC7479MR06 2377062-5 0.7T OPENSPEED EXITE PC3802MR02 2377062-5 1,5T HD ES/HS 10079MRM74 5107849 1.0T SIGNA LX PH0095MR01 2214149 1.0T SIGNA LX PC0125MR02 2189500-3 1.5 ECHOSPEED HD 16-CH 0850270514 2226300 1.5 ECHOSPEED HD 4-CH 200-AP 409838HDCMR1 46-294231G1 1.5 ECHOSPEED HD 4-CH 200-AP 940220MR1 2214149-2 1.5 ECHOSPEED HD 8-CH 400-A 1344119 2226300 1.5 ECHOSPEED HD 8-CH 400-A 2624537EXCITE 5107849-2 1.5 ECHOSPEED HD 8-CH 400-AP 760323MR 2214149-2 1.5 ECHOSPEED HD 8-CH 400-AP 60001MRS01 5323286-101 1.5 HDE 8CH 3882691524MRCTR 5139394-2 1.5 HISPEED 3882635801MRSOR 2226300 1.5 HISPEED 4C 412099MR1 2226300 1.5 HISPEED HD 8-CH 400-AP 317338MR4 2214149-2 1.5 HISPEED HD 8-CH 400-AP 803936MRI 2214149-2 1.5 LX TO HDX 16C FORKLIFT UPG 614293MR7 2214149-2 1.5 SIGNA EXPLORER DZ1947MR01 5323286-101 1.5 SIGNA EXPLORER DZ1149MR02 5323286-101 1.5 T ECHOSPEED HD 4-CH 200-AP 35067MRS01 5107849-2 1.5 T ECHOSPEED MRI LY1006MR01 2189500-3 1.5 TWINSPEED HD 8CH-400-AP 910716BMR1 2377062-2 1.5T BRIVO MR355 AZ4010MR01 5341543 1.5T BRIVO MR355 AZ4027MR01 5341543 1.5T BRIVO MR355 AZ4004MR01 5323286 1.5T BRIVO MR355 AZ4015MR01 5341380 1.5T BRIVO MR355 082427010062 2214149-2 1.5T BRIVO MR355 082427210103 5341543 1.5T BRIVO MR355 082427210079 5341543 1.5T BRIVO MR355 082427200079 2214149-2 1.5T BRIVO MR355 082427310067 5341543 1.5T BRIVO MR355 082427040
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.