FDA Device recall Z-1209-2013
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System
- FDA Device
- Class II
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class II recall of GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System 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-1209-2013 |
| 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, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD 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 # 284481HM9 283390HM3 282416HM7 300218HM5 296431HM0 294361HM1 296436HM9 278690HM3 285914HM8…Mfg Lot or Serial # 284481HM9 283390HM3 282416HM7 300218HM5 296431HM0 294361HM1 296436HM9 278690HM3 285914HM8 300212HM8 302728HM1 286892HM5 294373HM6 284475HM1 274212HM0 294150HM8 286871HM9 285458HM6 285464HM4 285905HM6 286889HM1 289113HM3 290003HM3 290018HM1 295187HM9 295708HM2 297795HM7 298512HM5 298518HM2 300206HM0 300209HM4 300905HM7 300911HM5 305123HM2 305132HM3 305141HM4 305300HM6 305303HM0 306320HM3 307364HM0 307373HM1 307376HM4 308186HM6 308923HM2 309476HM0 202350HM5 213385HM8 226223HM6 238928HM6 241057HM9 266117HM1 176965HM2 179337HM1 201787HM9 229961HM8 274239HM3 274891HM1 302722HM4 271715HM5 273786HM4 190565HM2 263639HM7 190926HM6 191138HM7 203039HM3 208218HM8 242119HM6 262861HM8 239003HM7 173924HM2 223179HM3 200595HM7 220569HM8 200583HM3 237533HM5 202684HM7 227617HM8 231629HM7 289983HM9 257774HM0 295726HM4 301810HM8 282422HM5 286886HM7 274218HM7 267655HM9 210567HM4 286868HM5 263617HM3 |
|---|
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-1209-2013%22
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