GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX UPGRADE, 1.5 HDX, 1.5 HDX
Check against the official notice below — it lists the full affected range.
GE Medical Systems is recalling approximately 5,200 MRI systems sold worldwide, including throughout the United States and internationally. The affected systems operate on Software Version 15.x or HD 16 and are sold under model names including ER 15T HDXT ECHOSPEED 16 CHANNEL, OC 1.5T HDX ECHOSPEED 8 CHANNEL, and SC 1.5T. The recall was initiated because the latest on-site software version may not have been reinstalled at some facilities after service activities were performed.
This software issue can result in medical images being flipped left-to-right and/or patient data mismatches between images and patient records. The recall document does not specify a remedy or recommended action for affected consumers to take.
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, 000000000R7742 (MP697620); N/A, 00000834BD4B76 (M2865810); 46-294231G1, 0002005-0607-9 (80040MRS02); N/A, 00000293242MR4 (GOLD00EU79); 5127452, 00000274388MR8 (M4160077); 2226300, 000000000R7586 (PL2130MR01); 2226300, 000000000R2785 (A5106403); N/A, N/A (083027060000499); 2226300, 000000000R5870 (A5177224); N/A, 000000000R4933 (C4194430); 2226300, 000000000R7628 (PL1807MR01); 5911000-4 , 00001201FMM0FJ (083027829345912); 2226300, 000000000R5979 (818713MR1); 5308573, 00000292202MR9 (706378MR2); 46-294231G1, 002003-1211-30 (KW1005MR02); 2226300, 000000000R5829 (PL1677MR01); 46-294231G1, 000099-1119-10 (A5401507); N/A, N/A (083027040099711); 46-294231G1, 002001-0530-21 (0920279017); 2377062-61, 00000010633YR6 (808433TMR2); 46-294231G1, 002001-1001-91 (PC1961MR01); 5308573, 00000300778MR8 (0856270046); 2226300, 000000000R5217 (PL1649MR01); N/A, N/A (PL0195MR01); 2226300, 000000000R4456 (70772MRS90); 5127452, 000000HDMR6307 (DK1297MR01); 2226300, 000000000R1970 (M4018076); 46-294231G1, 0000094-1209-4 (178SIGNA15); 2377062-2, 00000963500YM4 (0910272057); 46-294231G1, 002004-0211-05 (PC2703MR02); 46-294231G1, 002001-0301-23 (YM0731); 46-294231G1, 002003-0128-22 (YM2020); 2226300, 000000000R5133 (KAISERVJOMR); 5127452-3, 00001011BD6645 (082427040110); 46-294231G1, 0000098-0617-2 (414SIGNAHOR); 5308573, 00000294505MR3 (34407MRS01); 5107849, 00000275094MR1 (DZ1004MR02); 2226300, 000000000R6384 (0850270266); N/A, 00000000R7803A (2900429); 2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.