GE Medical Systems, LLC: Medical Device Recall in 2024 - (Recall #: Z-2475-2024)

SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

Class II

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: 082427110089, 082427110085, 082427040318, 082427010165, 082427030217, 082427160341, 082427190152, 082427110096, 82427100448, 082427290071, 082427160273, 082427090359, 082427230237, 082427130113, 082427130115, 082427130130, 082427160366, 082427030166, 82427210264, 082427070299, 082427040251, 082427120336, 082427200172, 082427010146, 082427040307, 082427010170, 082427010216, 082427090365, 082427270079, 082427010207, 082427010153, 082427030213, 082427030155, 082427310135, 082427110106, 082427160262, 082427070239, 082427310133, 082427070247, 082427230160, 082427210207, 082427160316, 82427230230, 082427200137, 82427200235, 082427160311, 082427120242, 082427200167, 082427140185, 082427160312, 082427160290, 082427250093, 082427160303, 082427100394, 82427170050, 082427170027, 082427170031, 082427100461, 082427110126, 082427110102, 082427190155, 082427090474, 082427100390, 082427120294, 082427150110, 082427160352, 082427160293, 082427070227, 082427210253, 082427310141, 082427240087, 82427120314, 082427120367, 82427070340, 082427220075, 082427220087, 082427140190, 082427060097, 082427090361, 082427290048, 082427290069, 082427290039, 082427160295, 082427160374, 082427160327, 082427160394, 82427160420, 082427160291, 82427160368, 082427160367, 082427160416, 082427160359, 082427160364, 082427180074, 82427180084, 082427240091, 82427240110, 082427240111, 082427170032, 082427170028, 082427070234, 082427070224, 082427070343, 082427070279, 082427070339, 082427070236, 82427070350, 082427070242, 082427070335, 082427070257, 082427010205, 082427010158, 82427010218, 082427010172, 082427010202, 82427090495, 082427210205, 082427210204, 082427190158, 082427190159, 082427190145, 82427190202, 082427190149, 82427190192, 082427190197, 082427190163, 082427120339, 082427120233, 082427120374, 082427120264, 082427120297, 082427120260, 082427200212, 082427200231, 082427200150, 082427200174, 082427200155, 82427200197, 082427200165, 82427020134, 082427020099, 082427020127, 082427020120, 082427020096, 082427030205, 082427030221, 082427030169, 82427060113, 082427060099, 082427230173, 082427010189, 082427100385, 082427100481, 082427100466, 082427100436, 082427100359, 082427100361, 082427100500, 082427100425, 082427310181, 082427310154, 082427310127, 082427310149, 082427310148, 082427230164, 82427230260, 82427230265, 082427230168, 082427230143, 082427230175, 082427230205, 082427230187, 082427270075, 082427270089, 082427250095, 082427140199, 082427250116, 082427250100, 082427250085, 082427250101, 082427060082, 82427060123, 082427040273, 082427040294, 082427040316, 82427040323, 82427040338, 082427020089, 82427020117, 082427020123, 082427020103, 082427230182, 082427230242, 082427230238, 082427230165, 82427110165, 082427110153, 082427110125, 082427110147, 082427110098, 82427100503, 082427100506, 082427100400, 082427100460, 082427080086, 082427080137, 082427080118, 082427080135, 082427080133, 082427080116, 082427080113, 082427080103, 82427160417, 082427160419, 082427160369, 082427160351, 082427160281, 082427160333, 082427160397, 82427160410, 82427160377, 082427160421, 082427160425, 082427160406, 082427270085, 082427120332, 082427120315, 082427120342, 82427120368, 082427120348, 082427120306, 082427120362, 82427200237, 082427200218, 082427200198, 82427200225, 82427200228, 082427200194, 082427200187, 082427200192, 082427200153, 082427210259, 082427070348, 082427070244, 082427070309, 082427070313, 082427070316, 82427070325, 82427070346, 082427070240, 082427070327, 082427070330, 082427070255, 082427070344, 082427070248, 082427070285, 082427070312, 082427090367, 082427090460, 82427090496, 82427090501, 082427140189, 082427140315, 082427140332, 082427210239, 082427210234, 82427210265, 082427190198, 082427190191, 082427190179, 082427220100, 082427290073, 082427290061, 082427290049, 082427260012, 082427240101, 082427240102, 082427240099, 082427240113, 082427240100, 082427240103, 082427240104, 082427030199, 082427030210, 082427030194, 82427030209, 082427030228, 082427030215, 82427030220, 082427030206, 082427030165, 082427030181, 082427220085, 082427220138, 82427220139, 082427310153, 082427040303, 082427310160, 082427010152, 82427010200, 82427010215, 82427010217, 082427010210, 082427010164, 082427010208, 082427010209, 082427010195, 082427010193

Worldwide distribution.

Voluntary: Firm initiated