FDA Device recall Z-1207-2013
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant
- FDA Device
- Class II
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class II recall of GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1207-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-08 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
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.
Reason
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
Identifiers
| code_info | Mfg Lot or Serial # 00000029854MR5 00000030086MR1 00000030154MR0 00000235678MR0 00000235678MR0 00000288408MR8 00…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 000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1207-2013%22
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