GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling certain MRI machines (Discovery MR750, Discovery 450, Optima 450W, Signa HDx, Signa HDxt, Signa HDi, and Signa Vibrant models) due to an image flip issue. When these machines create reformatted axial and coronal images from three-dimensional sagittal scans containing more than 126 slices—such as those using FSPGR-3D T1, BRAVO T1, or CUBE T1 applications—the images may display flipped from left to right. Additionally, the original sagittal images may have reversed left-right location annotations.
The recall affects 4,338 machines with specific serial numbers distributed worldwide, including throughout the United States (except Rhode Island). However, the recall record does not specify what consumers or healthcare facilities should do if they have an affected machine.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: 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 Quantity: 4338 Lot/code info: Mfg Lot or Serial # 00000029854MR5 00000030086MR1 00000030154MR0 00000235678MR0 00000235678MR0 00000288408MR8 00000289961MR5 00000290137MR9 00000292634MR3 00000292964MR4 00000292964MR4 00000293015MR4 00000293338MR0 00000293646MR6 00000293874MR4 00000293918MR9 00000294018MR7 00000294057MR5 00000294098MR9 00000294280MR3 00000294472MR6 00000294494MR0 00000294556MR6 00000294576MR4 00000294643MR2 00000294665MR5 00000294718MR2 00000294913MR9 00000294953MR5 00000295024MR4 00000295092MR1 00000295112MR7 00000295134MR1 00000295215MR8 00000295228MR1 00000295241MR4 00000295506MR0 00000295904MR7 00000296014MR4 00000296046MR6 00000296070MR6 00000296096MR1 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296307MR2 00000296369MR2 00000296418MR7 00000296429MR4 00000296461MR7 00000296462MR5 00000296469MR0 00000296512MR7 00000296517MR6 00000296573MR9 00000296595MR2 00000296602MR6 00000296626MR5 00000296640MR6 00000296821MR2 00000296829MR5 00000296840MR2 00000296860MR0 00000296888MR1 00000296894MR9 00000296908MR7 00000297006MR9 00000297134MR9 00000297147MR1 00000297355MR0 00000297374MR1 00000297387MR3 00000297469MR9 00000297493MR9 00000297624MR9 00000297649MR6 00000297833MR6 00000297880MR7 00000297891MR4 00000298050MR6 00000298083MR7 00000298181MR9 00000298247MR8 00000298248MR6 00000298249MR4 00000298283MR3 00000298310MR4 00000298334MR4 00000298386MR4 00000298387MR2 00000298399MR7 00000298474MR8 00000298494MR6 00000298512MR5 00000298535MR6 00000298537MR2 00000298552MR1 0000029857
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.