GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling approximately 5,200 MRI systems worldwide, including units distributed nationwide across the United States and internationally. The systems use Software Version 12.x and are sold under product names including SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, and MR GOLDSEAL 1.5T HD 8CH. The recall was issued because the latest on-site software version may not have been reinstalled at some facilities after service activities were performed, which could result in medical images being flipped left/right and/or patient data mismatches.
The recall notice does not specify what affected consumers or healthcare facilities should do to address this issue.
Written by software from the official notice below. Not reviewed by a lawyer.
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
Reason for recall: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. Distribution: Worldwide Distribution: US (nationwide) including states of:: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, 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 countries of: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chi Quantity: 5,200 total units Lot/code info: Model Number, Serial Number (System ID) : 2226300, 000000000R4938 (256329MR2); 2226300, 000000000R5598 (256ALOPMR); N/A, N/A (334699MR); 2377062-2, 00000002547YR8 (256265HMR); 5107849, 00000274691MR5 (205487MR2); 46-294231G1, 0002005-0411-5 (870972E16); 46-294231G1, 002005-1201-35 (623583MR1); 2377062-2, 00000963660YM6 (480323MR1); 5107849-2, 00000278561MR6 (818445MR); 46-294231G1, 002004-1028-04 (3825); 2377062, 00000941225YM5 (626335MR); 46-294231G1, 002004-0913-01 (3591); 46-294231G1, 002005-1018-15 (352333MR3T); N/A, N/A (954587MR1); 46-294231G1, 002002-0605-11 (781340MR); 5107849, 266201MR3 (RADNETMR1585); 46-294231G1, 002005-0110-28 (313593MR02); 5308573, 00000292781MR2 (609890MR); 2214149-2, 00000010224GQ4 (732745MR); 2377062-2, 00000963098YM9 (607798MREXCT); N/A, N/A (516825MR); N/A, N/A (405307NMR); N/A, N/A (814535MR1); 5107849-2, 00000283624MR5 (615588MRI); N/A, N/A (615473MR1); N/A, N/A (817922MRLX); 5107849-2, 00000278623MR4 (972378NSC3TMR1); 46-294231G1, 0002005-0823-7 (DZ1057MR01); 46-294231G1, 002006-0127-10 (DZ1193MR01); 2226300, 00000000R5456A (2722SIGNA15); 2226300, 000000000R6230 (4291EXC15T); 2226300, 000000000R4601 (MRR4601); 2226300, 000000000R4973 (0910272001); 2226300, 000000000R5899 (0910274027); M3000PT, 00000280570MR3 (0910273001); 46-294231G1, 002005-0511-13 (AZ1003MR01); 46-294231G1, 0000099-0111-2 (110037MR01); 46-294231G1, 002005-0301-06 (2560124); 2226300, 000000000R5054 (BA4073MR01); N/A, 000000000R6295 (2712857); 5308573, 00000290734MR3 (277
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.