FDA Device recall Z-1208-2013
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device
- FDA Device
- Class II
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class II recall of GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device 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-1208-2013 |
| 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, GE 1.5T SIGNA HDe MR SYSTEM. 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 # 00000004984YR1 00000005068YR2 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00…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 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-1208-2013%22
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