1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling approximately 653 1.5T and 3.0T SIGNA HDx, SIGNA HDxt, and SIGNA HDxt Mobile Magnetic Resonance Imaging Systems that were distributed worldwide, including throughout the United States and numerous countries across Europe, Asia, Africa, and the Americas. These MRI machines have a defect that can cause images to be flipped left to right, potentially affecting the accuracy of diagnostic imaging.
The source document does not specify a remedy or instructions for affected consumers on how to address this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential for the images to be flipped left to right.
Reason for recall: There is potential for the images to be flipped left to right. Distribution: Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syr Quantity: 653 units Lot/code info: System IDs: 907562P3T, 256734MR3T, 623879MR1, 623433MR1, 480584MR1, 602689MR1, 9287573TMR, 480324MR1, 480614MR1, 928317MR1, 714868MR1, RADNETMR615, 714619MR, 5107923TMR, 858657MR1, 323442MR3, 323442MR1, 213977MR2, 323932MR1, 323442MR2, RADNETMR612, 650259SM3T, RADNETMR1521, RADNETMR592, 626397MR2, RADNETMR620, 916DR3TMR, 415UCLPMR, 415600D3T, 415476UMR6, 415353MRC1, 415MTZMR, 408GS3TMR, RADNETMR1595, 408885MR3T, RADNETMR608, 805569MR, 415723SHMR8, 661AIMR2, RADNETMR594, 805CHLIMR1, 720848MR2, 303340MR, 030022MR01, 515282MR1, 859275MR3T, 2709263HD, 504873TMR3, 504DISWMR, 504DISMR3T, BEV3TMR, 9786823T, RADNETMR1659, RADNETMR1589, 207MMCSMR, 517353VH3, 269342MR3T, 269342MR3T2, 517374MR3T, 248465MR3T, 248849MR3T, 662MSU3T, 406751K3T, CONCORD3T, 201669MR2, 716859MR3T, NYP347652, 212305MR83T, 5857853T, 631686MR3T, 5853413TLAC, 419383MR3T, 503280MR2, 6109883TMR, 423844MR2, 865541MR3T, 615777MR3T, 936441MR1, 817882H3TMR, 513556MR, 713441MR5, 512TSIMR2, 210617TCAMR2, 210617TCAMR1, 801221MR, 509758TMR, 425288CMR, 2063203TMR, 414973MR2, 608785HDMR, 414649MR5, 414973MR1, 422SIGNA3T, 250374MRTS, 604682MRI, 604682MRI2, 604739MR, 082427120201, DK1030MR02, ET1009MR01, 493013MR01, HC1819MR01, 850270170, 850270218, MR281340MR0, DVT0127, PER19516, PER08626, RU1095MR03, ZA2222MR01, MPX82251, GP178328, FPG98423, FPG98415, MEX68900, DPN88605, ME051580, MPX10000, EPP00302, 725030MR01, 00149MRS01, 205939MR4, 205783TSMR, 2059393T, 928213MR3T, 480354MR1, 602588CMR1, 480464MR1, 4809643TMR, 954SIMON3T,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.