FDAFDA · Food and drugs·Recall number Z-1208-2013
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
Published May 8, 2013 · Recall initiated: June 8, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- 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 00000012117
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.