CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report

Optima MR360, with affected recalled by GE Medical Systems

GE Medical Systems is recalling Optima MR360, with affected. The recall was initiated on 14 Jun 2024 and the FDA has classified it as Class II.

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Lot, batch or date codesSystem 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

Quantity recalled469 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2478-2024
FDA event ID: 94874
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jun 2024
FDA classified: 2 Aug 2024
Reported: 14 Aug 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

14 Jun 2024	Recall initiated by company
2 Aug 2024	Classified by FDA	+49 days
14 Aug 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution.

Questions about this recall

Is Optima MR360, with affected recalled?

Yes. GE Medical Systems recalled Optima MR360, with affected on 14 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-2478-2024.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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