GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEED, 1.5T
Check against the official notice below — it lists the full affected range.
GE Medical Systems is recalling approximately 5,200 GE Healthcare MRI systems sold worldwide, including throughout the United States and multiple countries, under model names including 1.5T CXK4 LCC MAGNET, 1.5T EXCITE, and related variants. The recall addresses a software issue where the latest on-site software version may not have been reinstalled at some facilities after service activities were performed, potentially causing medical images to be flipped left/right and/or resulting in patient data mismatches.
The recall notice does not specify a remedy that affected consumers should pursue.
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) : N/A, 002003-0530-08 (GOLD010252), 46-294231G1, 002004-0406-06 (HC5300MR02), 46-294231G1, 000004-0311-16 (IE1053MR01), 2377062-2, 00000963562YM4 (0850270477), 2377062, 00000983439YM5 (0850270470), 46-294231G1, 002002-1021-51 (0850270122), 46-294231G1, 0000099-0809-8 (482180SIGNA), 2377062, 00000941219YM8 (561863MR1), N/A, N/A (0910272059), 2226300, 000000000R1040 (PL1124MR02), N/A, 0002005-0922-4 (00491MRS01), N/A, N/A (083027200000913), 2377062-2, 963531YM9 (559713CMIMR), 7452, 000000HDMR6133 (IE1111MR01), 46-294231G1, 002004-1028-17 (2059393T), N/A, 002004-0823-18 (M4135138); 46-294231G1, 002004-1115-13 (0850270170); 46-294231G1, 04 0211-4 (912354MRI); 46-294231G1, 002004-1109-02 (44EXCITE2550834); 46-294231G1, 002004-0913-16 (YM4157); 46-294231G1, 002005-0914-20 (YM1414); 46-294231G1, 002003-0708-02 (YM2028); 2226300, 0000000R7722 (1337081); 2377062-2, 00000951060YM3 (MRR7674); 2226300, 000000000R3880 (083027602171311); 2357500-2, 00000268322MR5 (MRR0455); 2214149-2, 00000006147M23 (1347499); 2377062-2, 00000956341YM2 (2682089); 2357500-2, 00000281517MR3 (2641178); 2226300, 000000000R5825 (2682131); 2377062-2, 00000963279YM5 (083027846014410); 2226300, 000000000R5837 (1238483); 2226300, 000000000R5419 (48MRE2744667); N/A, N/A (299SIGEXC); N/A, N/A (H1787MR11); 2226300, 000000000R7325 (2850446); 2226300, 000000000R7402 (PPR94108; 2357500-2, 00000272881MR4 (UPW21614); 2377062-2, 00000963044YM3 (MPX39916); 2377062, 00000962662YM3 (A591
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.