FDAFDA · Food and drugs·Recall number 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. 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 # 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 266951HM3 254615HM8 187938HM6 196629HM0 238231HM5 282404HM3 167486HM0 199901HM0 193891HM9 173912HM7 170636HM5 294147HM4 244336HM4 292524HM6 179350HM4 170947HM6 233942HM2 162548HM2 293800HM9 227765HM5 286874HM3 230345HM1 174556HM1 213014HM4 192701HM1 238597HM9 184917HM3 268113HM8 221655HM4 254616HM6 269129HM3 283384HM6 281434HM1 283387HM9 285455HM2 285449HM5 250051HM0 265004HM2 257789HM8 256150HM4 235822HM4 176555HM1 206273HM5 264194HM2 267204HM6 293080HM8 262350HM2 268124HM5 211504HM6 195579HM8 202478HM4 252485HM8 187478HM3 297798HM1 285461HM0 267698HM9 249448HM2 286027HM8 260953HM5 210554HM2 265012HM5 193026HM2 211535HM0 269423HM0 172347HM7 266962HM0 195447HM8 262850HM1 294144HM1 206272HM7 267685HM6 170573HM0 173420HM1 293095HM6 195469HM2 226804HM3 222527HM4 208276HM6 241705HM3 297318HM8 297813HM8 237249HM8 187075HM7 170080HM6 294141HM7 186769HM6 297816HM1 293809HM0 208920HM9 247326HM2 293803HM3 172348HM5 298503HM4 237600HM2 191146HM0 286030HM2 296445HM0 247348HM6 187173HM0 238213HM3 292530HM3 295717HM3 297303HM0 297789HM0 307336HM8 307351HM7 307354HM1 307367HM3 307379HM8 308180HM9 308907HM5 202345HM5 204158HM0 205908HM7 206819HM5 210513HM8 213193HM6 214041HM6 214712HM2 215676HM8 216125HM5 217358HM1 218474HM5 219406HM6 223599HM2 224698HM1 224707HM0 229042HM7 230858HM3 231784HM0 234987HM6 242129HM5 243112HM0 244329HM9 245315HM7 250988HM3 252871HM9 256318HM7 265044HM8 267712HM8 271741HM1 305144HM8 305150HM5 305312HM1 305321HM2 305845HM0 306311HM2 306314HM6 307370HM7 308183HM3 219021HM3 222105HM9 228098HM0 245639HM0 257108HM1 262327HM0 305833HM6 305836HM9 308915HM8 185938HM8 189596HM0 228549HM2 230620HM7 230848HM4 245161HM5 245629HM1 245857HM8 249436HM7 255984HM7 273783HM1 203048HM4 165776HM6 286655HM6 240141HM2 168931HM4 188073HM1 224463HM0 247337HM9 254973HM1 199889HM7 191893HM7 168298HM8 263628HM0 250039HM5 269994HM0 252414HM8 252417HM1 282419HM1 250054HM4 271721HM3 250042HM9 252422HM1 280553HM9 289380HM8 290009HM0 290012HM4 290015HM7 295720HM7 297804HM7 300215HM1 300221HM9 302713HM3 302719HM0 305126HM5 305135HM6 305138HM0 305309HM7 306418HM5 306421HM9 306424HM3 307361HM6 308527HM1 308531HM3 308920HM8 218302HM8 271724HM7 276201HM1 281225HM3 168057HM8 170946HM8 186296HM0 188082HM2 189689HM3 205587HM9 205674HM5 212413HM9 270536HM6 271417HM8 282428HM2 282431HM6 267658HM3 289110HM9 297807HM0 274221HM1 242952HM0 289100HM0 285452HM9 282425HM8 263670HM2 263682HM7 297810HM4 307382HM2 212655HM5 269453HM7 271611HM6 273792HM2 278693HM7 281437HM4 225162HM7 169412HM4 187748HM9 300908HM1 175854HM9 186765HM4 187012HM0 289116HM6 296428HM6 297315HM4 210900HM7 217759HM0 267201HM2 236458HM6 184419HM0 269418HM0 293794HM4 219128HM6 257819HM3 210890HM0 192199HM8 178541HM9 193224HM3 281419HM2 179953HM
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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