Z-2478-2024 Class II Ongoing

Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

System ID: 1009000, 201871MR, DZ1396MR01, DZ1820MR01, DZ1339MR02, DZ1339MR01, DZ1061MR01, DZ1406MR01, DZ1285MR01, DZ1191MR01, 0910272060, 0910274038, 0910274036, BH1038MR01, MRR9112, MRR10326, MRR8777, MRR10248, MRR9308, MRR10649, MRR10657, MRR10586, MRR10646, MRR10703, MRR10694, MRR10648, MRR10676, MRR8247, MRR10417, MRR10842, MRR10620, MRR10145, MRR9922, MRR9979, MRR10393, MRR9829, MRR8339, MRR11105, MRR10416, MRR10514, MRR10812, MRR9091, MRR10742, MRR8318, MRR10418, MRR9927, MRR8632, MRR8679, MRR8213, MRR9379, MRR10692, MRR10259, MRR10205, MRR10330, MRR11034, MRR9826A, MRR10690, MRR9033, MRR10478, MRR10529, MRR8249, MRR9080, MRR8969, MRR10201, MRR8714, MRR10793, MRR10013A, MRR8427, MRR11089, MRR10594, MRR9435, MRR10177, MRR10629, MRR10366, MRR10640, MRR10596, MRR9988, MRR10158, MRR10486, MRR9587, MRR10341, MRR10388, MRR10147, MRR10206, MRR9797, MRR9636A, MRR9450, MRR9947, MRR9271, MRR10227, MRR10062, MRR9000, MR1551SX1, MRR10336, MRR10115, MRR9877, MRR10726, MR1578SX4, MR1462SX1, MRR9318, MRR10645, MRR10218, MRR10076, MRR8392, MRR8861, MRR8835, MRR8194, MRR10584, MR1532SX1, MRR8424, MRR10442, MRR10885, MRR8415, MRR10603, MRR10606, MRR10619, MR1179SX1, MRR10656, MRR9500, MRR10680, MRR10143, MRR10082, MRR10065, MRR9544, MRR8831, MRR11307, MRR10642, MRR9043, 082427040158, 082427040159, 082427040131, 082427040134, 082427040136, 082427040138, 082427220034, 082427040156, 082427120128, 082427200082, 082427010067, 082427240051, 082427270031, 082427160112, 082427090225, 082427040130, 082427120140, 082427120139, 082427120123, 082427060036, 082427010068, 082427070165, 082427050035, 082427100179, 082427210089, 082427140118, 082427240036, 082427120111, 082427060054, 082427160119, 082427160093, 082427100209, 082427210112, 082427230086, 082427120105, 082427250035, 082427100205, 082427030083, 082427100197, 082427160102, 082427020051, 082427120108, 082427060045, 082427070085, 082427090182, 082427060041, 082427120115, 082427190055, 082427080035, 082427270038, 082427130070, 082427090222, 082427090203, 082427160116, 082427160115, 082427160111, 082427160092, 082427160121, 082427240029, 082427240026, 082427070121, 082427070088, 082427070106, 082427070093, 082427210122, 082427070105, 082427070124, 082427070118, 082427090239, 082427090210, 082427090219, 082427090236, 082427090209, 082427090207, 082427210117, 082427210140, 082427210100, 082427210104, 082427190061, 082427120094, 082427030087, 082427030085, 082427060047, 082427060053, 082427300016, 082427060044, 082427060050, 082427310106, 082427090213, 082427190094, 082427100190, 082427130068, 082427100177, 082427100193, 082427100212, 082427100222, 082427100178, 082427100174, 082427100206, 082427100196, 082427100195, 082427100180, 082427100188, 082427080039, 082427310088, 082427310043, 082427270047, 082427270041, 082427140095, 082427250043, 082427060043, 082427060039, 082427300017, 082427100152, 082427100203, 082427100186, 082427100171, 082427080045, 082427180024, 082427270036, 082427120096, 082427120119, 082427120109, 082427200057, 082427070084, 082427070082, 082427070099, 082427070080, 082427070086, 082427090217, 082427140092, 082427190074, 082427030075, 082427030072, 082427030091, 082427310052, MRR8406, EG1925MR01, EG3053MR01, EG1840MR02, EE4024MR01, 782057MR01, PC2287MR01, PC0395MR02, 805466MR03, 363893MR01, PC4529MR01, 782692MR01, HC7831MR01, 734128MR01, 164236MR02, H4678MR04, MRR8465, MRR8457, 083027105723017, 083027820014211, 083027288790310, 083027201106511, 083027842022620, 083027801024814, 083027808008011, 083027849290410, 083027000013013, 083027600004313, 0835270028, 0835270027, IQ1309MR01, A5714101, A106327806, PC0098, PC0089, PC0107, PC0075, PC0078, PC0048, PC0047, PC0049, PC0071, PC0050, PC0090, PC0115, PC0117, PC0085, PC0096, PC0057, PC0083, PC0087, PC0067, PC0082, PC0046, PC0052, PC0105, PC0110, PC0091, PC0068, PC0133, PC0130, PC0088, PC0122, PC0076, PC0101, PC0084, PC0074, PC0053, PC0086, PC0064, PC0042, PC0032, PC0111, PC0054, PC0103, PC0094, PC5005, PC0061, PC0065, PC0069, PC6102, PC0079, PC0041, PC0120, PC0077, PC0106, PC0066, PC0063, PC0039, PC0036, PC0097, PC0044, PC0051, PC0062, PC0109, PC0123, PC0102, PC0043, PC0035, PC0095, JO1147MR01, 0850270360, 0850270375, 0850270405, 0850270397, 0850270366, 0850270387, 0850270382, 0850270373, 0850270368, LV4012MR02, LV4031MR01, LB1359MR01, LB1088MR02, LB1358MR01, LB1364MR01, LT4026MR01, LT4043MR01, 2836414HDE, MRR8505, MA1134MR01, MA1487MR01, MA1471MR01, NG1126MR01, NO1200MR01, 0843270022, PL1620MR01, PL2059MR01, PL1798MR01, P00571MR01, PL2433MR01, PL1321MR01, PL2435MR01, PL2854MR01, P00607MR01, PL1951MR01, PPR44921, PPS07404, RO1105MR01, RO1223MR01, RF1709MR01, RF2036MR01, RU7690MR01, RU4356MR01, RU1130MR01, RU8412MR01, RU1346MR01, RU1136MR01, RU1875MR01, 600100MR03, RU1146MR01, RU3883MR01, RU1820MR02, SA2305MR01, SA2352MR01, SA2191MR04, SA2253MR01, SA1056MR03, ZA2198MR01, ZA2383MR01, MPX82245, UP925712, NPV86500, EPP04112, DPN95902, DPL32939, MPD24000, GPQ13902, NPV82605, UPW07802, MPX09800, FPG08503, MP720818, MPX75606, DPN79400, MPD19500, DPN62603, EPP11100, SY2060MR01, SY2058MR01, 0853270123, 0853270131, 0853270134, 0853270139, 0853270126, 0856270052, 0856270049, TN1033MR02, TN1241MR01, TN1008MR01, TN1530MR01, 16048MRS01, 16049MRS02, 34337MRS01, 42021MRS01, 68008MRS01, 34346MRS01, AE1373MR01, UZ1337MR01, 3882941838MRCTR, 3882928195MRMET, 0859270015, 0859270014, 0859270009, 0859270008