Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Summary
The FDA issued a Class II for Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; N by GE Medical Systems, LLC. Reason: 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 scannin.
Details
Source
Device Recall
External ID
Z-2477-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Lot/Code Info: System ID: MSF067-1-6AB94D05, DZ1570MR01, MRR9492, MRR10103, MRR10449, MRR9613, MRR9196, MRR9924, MRR9725, MRR10479, MRR9358, MRR9372MM3, MRR9496, 083027600051013, MRR8258, MRR10217, MRR8634, MRR9104, MRR10184, MRR9949, MRR8550, MRR9286, MRR9231, MRR9153, MRR8685, MRR10207, MRR8755, MRR9962, MRR8669, MRR8972, MRR9920, MRR10124, MRR10693, MRR10081, MRR9131, MRR8647, MRR9484, MRR8609, MRR10162, MR1714SX5, MRR8984, MRR8602, MRR10063, MRR9968, MRR9037, MRR9980, MRR9811, MRR10213, MRR10237, BG4608MR01, MRR9350, MRR9031, 082427110037, 082427110039, 082427220030, 082427220032, 082427220029, 082427220028, 082427190073, 082427210085, 082427150052, 082427150046, 082427030077, 082427160108, 082427170015, 082427170018, 082427040126, 082427200069, 082427010062, 082427010058, 082427210126, 082427200055, 082427290012, 082427160099, 082427230062, 082427090205, 082427270043, 082427310049, 082427160125, 082427160120, 082427090185, 082427110057, 082427160096, 082427230076, 082427100157, 082427150054, 082427150055, 082427160109, 082427180025, 082427180026, 082427240033, 082427240027, 082427240032, 082427210086, 082427070092, 082427070077, 082427090158, 082427090199, 082427090154, 082427090216, 082427090156, 082427090191, 082427090167, 082427090172, 082427090152, 082427090197, 082427090177, 082427090243, 082427210067, 082427210088, 082427210095, 082427190063, 082427190056, 082427190054, 082427190052, 082427190062, 082427190060, 082427190059, 082427190057, 082427190058, 082427200059, 082427200054, 082427200051, 082427200061, 082427200085, 082427200079, 082427200067, 082427200070, 082427020048, 082427020043, 082427020046, 082427030068, 082427200096, 082427090155, 082427100167, 082427100163, 082427100155, 082427100162, 082427310067, 082427230072, 082427230071, 082427230054, 082427230066, 082427230060, 082427270035, 082427060037, 082427020040, 082427230070, 082427110038, 082427100151, 082427120127, 082427200060, 082427200044, 082427200063, 082427200064, 082427070076, 082427070091, 082427090184, 082427090183, 082427090186, 082427170017, 082427210103, 082427210079, 082427210092, 082427190051, 082427190068, 082427150049, 082427240040, 082427220025, 082427310055, 082427310051, 082427010059, MRR8316, MRR10123, MRR9787, MRR8587, MRR8724, MRR9448, MRR8333, MRR9530, 2943672BRIVO, MRR8727, MRR9190, MRR8270, 805609MR01, GH5014MR01, MR5407GT, MRR8813, 083027600033412, 083027280005313, 083027280035313, 083027000002713, 083027240003113, 083027240009512, 083027240046912, 083027100004713, 083027100020013, 083027820034810, 083027860004512, 083027861104811, 083027868443311, 083027860028112, 083027200051414, 083027200494913, 083027208469611, 083027206189511, 083027201003119, 083027200037012, 083027207329111, 083027200044913, 083027205952123, 083027060039211, 083027044291311, 083027800002313, 083027800405712, 083027805544513, 083027849928710, 083027601012912, 083027607456310, 0835270033, 0835270043, 0835270030, 0835270023, 0835270047, A5163111, A364241704, MR332876HM2, MRR8312, PC5014, PC5022, PC5059, PC5079, PC5010, PC5017, PC5047, PC5073, PC5035, PC5045, PC5056, PC5060, PC5151, PC5072, PC5100, PC5033, PC5069, PC5001, PC5140, PC5015, PC5008, PC5023, PC5038, PC5025, PC5071, PC5046, PC5021, PC5150, PC5052, PC5039, PC5007, PC5051, PC5078, PC5049, PC5064, PC5057, PC5019, PC5044, PC5016, PC5076, PC5066, PC5036, PC5031, PC5011, PC5048, PC5018, PC5043, PC5054, PC5055, PC5003, PC5050, PC5040, PC5090, PC5067, PC5024, PC5063, PC5013, PC5026, PC5053, PC5068, PC5028, PC5061, PC5030, PC5037, PC5027, PC5006, PC5042, 0850270356, 0850270349, 0850270429, 0850270378, 0850270364, 0850270383, 0850270352, LV4058MR01, MRR8614, MA1085MR01, MA1421MR01, MA1014MR02, NG1065MR01, NG1127MR01, NG1097MR01, PL2893MR01, PL2997MR01, PL1809MR01, PL2717MR01, RO1221MR01, RU7464MR01, RU3028MR01, RU5248MR01, RU6147MR01, RU1203MR01, RU1778MR01, RU7816MR01, RU3240MR01, RU7539MR01, RU2652MR02, RU3908MR01, RU8225MR01, RU1997MR01, RU3759MR01, RU2607MR01, RU2272MR01, RU7426MR01, RU8300MR01, RU6261MR01, RU3609MR01, RU7865MR01, RU8407MR01, RU7312MR01, RU4306MR01, RU3794MR01, RU7827MR01, RU3469MR01, RU3776MR01, RU3951MR01, RU8151MR01, RF2883MR01, A5940817, ZA2315MR01, ZA2471MR01, UPW01801, PPS68403, MPD34400, NPD03800, 0856270060, 0856270059, 0856270058, 0856270056, 0856270057, 0856270051, 0856270069, 06138MRS01, 09015MRS01, 13007MRS01, 34340MRS01, 34334MRS01, 46014PRO06, 46014MRS01, 46016MRS01, 55021MRS01, 07027MRS01, 48005MRS01, UZ1020MR01, 0859270016, 0859270017, 0859270018,
Quantity Affected: 375 units
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-14
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2477-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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