Device Recall GE 1.5T SIGNA HDe MR SYSTEM

Mfg Lot or Serial # 00000004984YR1 00000005068YR2 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00000005656YR4 00000005659YR8 00000005664YR8 00000006155YR6 00000006157YR2 00000006172YR1 00000006176YR2 00000006177YR0 00000006188YR7 00000006194YR5 00000006198YR6 00000006200YR0 00000006204YR2 00000006514YR4 00000006515YR1 00000006516YR9 00000006519YR3 00000006522YR7 00000006525YR0 00000006528YR4 00000006532YR6 00000006535YR9 00000006538YR3 00000006544YR1 00000007947YR5 00000007954YR1 00000007969YR9 00000007970YR7 00000007971YR5 00000008692YR6 00000008698YR3 00000008699YR1 00000008701YR5 00000008703YR1 00000008709YR8 00000008715YR5 00000008716YR3 00000008720YR5 00000008726YR2 00000008727YR0 00000008728YR8 00000008729YR6 00000008732YR0 00000008734YR6 00000009833YR5 00000010024YR8 00000010025YR5 00000010114YR7 00000010578YR3 00000010580YR9 00000010583YR3 00000010686YR4 00000010794YR6 00000010795YR3 00000010830YR8 00000010831YR6 00000010834YR0 00000010856YR3 00000010863YR9 00000011210YR2 00000011428YR0 00000011429YR8 00000011495YR9 00000011499YR1 00000011637YR6 00000011648YR3 00000011650YR9 00000011669YR9 00000011686YR3 00000011826YR5 00000011829YR9 00000011830YR7 00000011842YR2 00000012085YR7 00000012098YR0 00000012099YR8 00000012100YR4 00000012102YR0 00000012142YR6 00000012172YR3 00000012206YR9 00000012207YR7 00000012221YR8 00000012227YR5 00000012286YR1 00000012287YR9 00000012289YR5 00000012330YR7 00000012393YR5 00000012434YR7 00000012435YR4 00000012503YR9 00000012507YR0 00000012576YR5 00000012651YR6 00000012652YR4 00000012727YR4 00000012728YR2 00000012755YR5 00000012756YR3 00000012818YR1 00000012820YR7 00000012940YR3 00000012943YR7 00000012988YR2 00000012992YR4 00000012994YR0 00000012995YR7 00000013056YR7 00000013061YR7 00000013177YR1 00000013180YR5 00000013185YR4 00000013239YR9 00000013241YR5 00000013246YR4 00000013301YR7 00000013306YR6 00000013310YR8 00000013375YR1 00000013379YR3 00000013384YR3 00000013385YR0 00000013399YR1 00000013453YR6 00000013799YR2 00000013800YR8 00000013802YR4 00000013804YR0 00000013878YR4 00000013880YR0 00000014113YR5 00000014114YR3 00000014214YR1 00000014276YR0 00000014277YR8 00000014520YR1 00000014524YR3 00000014801YR5 00000014806YR4 00000014858YR5 00000014859YR3 00000014907YR0 00000014909YR6 00000014910YR4 00000014956YR7 00000015146YR4 00000013380YR1 00000011535YR2 00000012209YR3 00000014414YR7 00000006174YR7 00000006507YR8 00000010827YR4 00000012144YR2 00000012497YR4 00000012575YR7 00000012753YR0 00000012991YR6 00000013693YR7 00000013875YR0 00000014415YR4 00000014419YR6 00000014620YR9 00000011692YR1 00000012367YR9 00000012508YR8 00000012550YR0 00000012722YR5 00000012942YR9 00000013305YR8 00000013451YR0 00000013626YR7 00000013805YR7 00000013876YR8 00000013877YR6 00000012796YR9 00000007964YR0 00000008704YR9 00000009948YR1 00000010023YR0 00000010685YR6 00000010833YR2 00000011827YR3 00000011824YR0 00000013057YR5 00000006181YR2 00000006183YR8 00000006184YR6 00000006185YR3 00000006186YR1 00000007951YR7 00000007952YR5 00000008688YR4 00000008689YR2 00000008705YR6 00000008706YR4 00000008707YR2 00000008708YR0 00000008710YR6 00000008711YR4 00000008712YR2 00000008730YR4 00000008731YR2 00000008733YR8 00000009832YR7 00000010227YR7 00000010231YR9 00000010250YR9 00000010253YR3 00000010579YR1 00000010754YR0 00000010755YR7 00000010857YR1 00000010860YR5 00000010862YR1 00000011186YR4 00000011211YR0 00000011212YR8 00000011238YR3 00000011290YR4 00000011343YR1 00000011349YR8 00000011537YR8 00000011539YR4 00000011638YR4 00000011639YR2 00000011649YR1 00000011652YR5 00000011653YR3 00000011685YR5 00000011689YR7 00000011690YR5 00000011828YR1 00000011840YR6 00000011961YR0 00000011963YR6 00000011964YR4 00000011987YR5 00000011991YR7 00000011992YR5 00000012103YR8 00000012117YR8 00000012118YR6 00000012119YR4 00000012141YR8 00000012147YR5 00000012171YR5 00000012366YR1 00000012368YR7 00000012389YR3 00000012390YR1 00000012391YR9 00000012449YR5 00000012551YR8 00000012579YR9 00000012580YR7 00000012581YR5 00000012582YR3 00000012723YR3 00000012729YR0 00000012875YR1 00000012876YR9 00000012879YR3 00000012880YR1 00000012936YR1 00000012937YR9 00000012993YR2 00000013055YR9 00000013092YR2 00000013135YR9 00000013238YR1 00000013240YR7 00000013244YR9 00000013245YR6 00000013249YR8 00000013303YR3 00000013309YR0 00000013347YR0 00000013377YR7 00000013397YR5 00000013445YR2 00000013446YR0 00000013448YR6 00000013452YR8 00000013576YR4 00000013577YR2 00000013578YR0 00000013579YR8 00000013580YR6 00000013582YR2 00000013585YR5 00000013617YR6 00000013618YR4 00000013619YR2 00000013620YR0 00000013622YR6 00000013695YR2 00000013696YR0 00000013697YR8 00000013699YR4 00000013700YR0 00000013701YR8 00000013702YR6 00000013810YR7 00000013914YR7 00000013915YR4 00000013916YR2 00000013935YR2 00000013936YR0 00000013937YR8 00000014058YR2 00000014059YR0 00000014069YR9 00000014104YR4 00000014105YR1 00000014109YR3 00000014110YR1 00000014112YR7 00000014212YR5 00000014213YR3 00000014215YR8 00000014216YR6 00000014217YR4 00000014278YR6 00000014327YR1 00000014329YR7 000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111YR9 00000014401YR4 00000014403YR0 00000014455YR0 00000014517YR7 00000014912YR0 00000013095YR5 00000015091YR2 00000011767YR1 00000010977YR7 00000011538YR6 00000012226YR7 00000012577YR3 00000012658YR1 00000013094YR8 00000013203YR5 00000012573YR2 00000013381YR9 00000013645YR7 00000012205YR1 00000012938YR7 00000014063YR2 00000011035YR3 00000011498YR3 00000011962YR8 00000011989YR1 00000013243YR1 00000013343YR9 00000006539YR1 00000006551YR6 00000008719YR7 00000008721YR3 00000010254YR1 00000011037YR9 00000012754YR8 00000014060YR8 00000014071YR5 00000015092YR0 00000006156YR4 00000010225YR1 00000012547YR6 00000012819YR9 00000005077YR3 00000006169YR7 00000008694YR2 00000008713YR0 00000008714YR8 00000010226YR9 00000011432YR2 00000012210YR1 00000004773YR8 00000005082YR3 00000006196YR0 00000006521YR9 00000006545YR8 00000006550YR8 00000010230YR1 00000012823YR1 00000013304YR1 00000013307YR4 00000013376YR9 00000010229YR3 00000014211YR7 00000012083YR2 00000013179YR7 00000012328YR1 00000012990YR8 00000013450YR2 00000014753YR8 00000015001YR1 00000006527YR6 00000006547YR4 00000011532YR9 00000013382YR7 00000013623YR4 00000013627YR5 00000013628YR3 00000013703YR4 00000013807YR3 00000014061YR6 00000014064YR0 00000010252YR5 00000012797YR7 00000005072YR4 00000005074YR0 00000006203YR4 00000006510YR2 00000006511YR0 00000006523YR5 00000006530YR0 00000006533YR4 00000006534YR2 00000006541YR7 00000006542YR5 00000006543YR3 00000006553YR2 00000006554YR0 00000010939YR7 00000010976YR9 00000012552YR6 00000012553YR4 00000012574YR0 00000012793YR6 00000012794YR4 00000012878YR5 00000012996YR5 00000013058YR3 00000013059YR1 00000013204YR3 00000013378YR5 00000013629YR1 00000013757YR0 00000014328YR9 00000014417YR0 00000014456YR8 00000011838YR0 00000006199YR4 00000010115YR4 00000011536YR0 00000012290YR3 00000014518YR5 00000015533YR3 00000015534YR1 00000015535YR8 00000015536YR6 00000015576YR2 00000015577YR0 00000015578YR8 00000015579YR6 00000015632YR3 00000015644YR8 00000015687YR7 00000015688YR5 00000015693YR5 00000015694YR3 00000015725YR5 00000015746YR1 00000015868YR3 00000006175YR4 00000006195YR2 00000008700YR7 00000008722YR1 00000008724YR7 00000010581YR7 00000011496YR7 00000011668YR1 00000012101YR2 00000012145YR9 00000012146YR7 00000012149YR1 00000012792YR8 00000013308YR2 00000014065YR7 00000014458YR4 00000014622YR5 00000014621YR7

Radiology Devices

2

No

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.

GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. || Indicated for use as a diagnostic imaging device.