medical Class II Updated 2022-04-13

GE Healthcare, LLC recalls 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resona

Recalled Product

1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System


Hazard / Issue

There is potential for the images to be flipped left to right.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: System IDs: 928223MR3T, 360397MR2, 602406IMR, 480323MR1, 928SMIMR, 3825, 559325CIIMR1, 805988MR2, 6617263TMR, 650306SMR3T, 4036, 3600, 3266, 818RIMR3T, 4267, 352333MR3T, 407SOMR3T, 941PCMR, 386HPOMR, ALLIANCESIG463, 337261MR1, 601288MR3T, 662841MR4, 336713WFUMR, 609383MR, 201487MR, 805998MR1, 805998CR1, 702369SM3TLV, 405634S3T, 814234MR, 6053883T, 731425MR2, 901425MROP1, 806212MR3T, 409892SMR2, 972566MR3, 972378NSC3TMR1, 801377MR2, 910277003, 2577595, 082427090088, 082427210045, 082427270017, 082427160041, 082427040047, 082427040052, 082427040074, 082427210039, 082427090090, 082427310027, 082427100093, 082427140039, 082427030039, 082427100099, 082427100084, 082427070050, 082427070034, 082427310019, 082427100089, IR1503MR01, A5125121, A5806911, YM3034, 850270175, 850270176, 850270199, 850270361, 850270205, KW1004MR03, RF0754MR01, GEE34040, 0853270071, 0853270072, 34208MRS01, 34006MRS03
View official government recall

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