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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description 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.
Recall Number Z-1209-2013
Classification Class II
Code Info 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 179953HM5 242143HM6 269409HM9 229427HM0 261011HM1 265007HM5 267652HM6 261005HM3 250465HM2 257783HM1 276180HM7 293127HM7 266900HM0 185390HM2 259654HM2 293092HM3 187162HM3 250459HM5 267643HM5 293130HM1 280902HM8 283381HM2 245745HM5 257792HM2 196358HM6 265001HM8 252375HM1 261008HM7 245624HM2 269309HM1 267646HM8 257780HM7 293089HM9 193207HM8 252396HM7 295723HM1 296425HM2 297321HM2 297792HM4 298506HM7 298509HM1 298515HM8 305147HM1 306415HM1 307327HM7 307330HM1 307333HM5 305842HM7 182226HM1 187469HM2 188934HM4 254619HM0 291203HM8 305318HM8 306308HM8 188814HM8 265023HM2 189945HM9 256448HM2 259663HM3 305306HM3 291784HM7 204173HM9 289103HM4 261730HM6 300914HM9 181534HM9 221022HM7 217783HM0 192378HM8 280559HM6 208928HM2 193130HM2 177380HM3 305129HM9 247878HM2 198004HM4 198790HM8 224716HM1 245556HM6 274215HM3 280905HM1 281443HM2 309473HM7 197709HM9 259648HM4 223609HM9 264183HM5 281277HM4 224451HM5 249456HM5 196791HM8 216112HM3 235831HM5 259410HM9 245748HM9 185608HM7 214982HM1 230838HM5 263688HM4 256433HM4 262310HM6 268809HM1 168747HM4 194588HM0 202467HM7 278684HM6 281428HM3 286880HM0 299936HM5 300200HM3 167093HM4 241081HM9 284466HM0 229562HM4 262295HM9 259420HM8 252402HM3 276192HM2 261736HM3 264992HM9 175009HM0 176123HM8 176952HM0 194652HM4 206783HM3 210539HM3 213393HM2 224442HM4 226020HM6 230214HM9 293118HM6 294820HM6 266894HM5 266897HM8 271733HM8 281440HM8 291778HM9 281431HM7 263673HM6 261733HM0 182601HM5 200902HM5 205894HM9 226420HM8 226780HM5 252497HM3 297822HM9 252393HM4 256141HM3 257771HM6 257798HM9 207286HM6 264554HM7 286898HM2 286901HM4 212641HM5 236222HM6 256156HM1 257768HM2 165275HM9 252380HM1 256424HM3 263676HM9 276207HM8 290033HM0 248583HM7 250462HM9 264983HM8 175614HM7 206808HM8 264586HM9 262298HM3 207131HM4 284460HM3 250048HM6 259657HM5 190053HM9 298500HM0 252411HM4 197721HM4 214032HM5 264980HM4 286649HM9 198712HM2 204139HM0 295732HM2 165274HM2 289091HM1 183671HM7 218943HM9 233375HM5 260996HM4 262286HM8 262289HM2 183345HM8 197244HM7 247882HM4 276204HM5 278687HM9 285902HM3 264986HM1 264998HM6 280556HM2 290036HM3 293812HM4 297819HM5 300197HM1 250057HM7 184795HM3 270513HM5 271706HM4 295729HM8 297324HM6 252408HM0 216086HM9 293121HM0 257777HM3 276210HM2 278672HM1 281425HM9 284463HM7 285911HM4 289096HM0 297306HM3 297327HM9 242138HM6 223718HM8 263691HM8 228528HM6 256153HM8 282413HM4 292521HM2 300203HM7 301816HM5 301819HM9 302734HM9 302737HM2 305153HM9 305156HM2 308177HM5 308929HM9 309506HM4 309509HM8 310727HM3 311241HM4 312231HM4 312379HM1 194662HM3 223449HM0 264205HM6 276198HM9 171699HM2 269456HM0 291215HM2 278675HM4 266903HM4 266906HM7 278678HM8 267634HM4 281422HM6 263685HM0 268812HM5 264989HM5 269447HM9 274224HM5 199733HM7 181103HM3 180699HM1 171698HM4 229582HM2 224689HM0 293124HM4 302716HM6 270510HM1 243170HM8 196395HM8 290030HM6 199942HM4 290024HM9 227474HM4 241065HM2 265034HM9 222113HM3 210288HM7 193196HM3 297801HM3 257843HM3 240130HM5 170081HM4 227429HM8 235191HM4 309470HM3 256144HM7 273789HM8 257546HM2 226814HM2 262319HM7 214907HM8 172794HM0 198684HM3 241050HM4 172560HM5 239726HM3 262304HM9 281416HM8 291206HM1 291209HM5 292527HM9 293083HM2 293086HM5 293133HM5 293806HM6 294367HM8 294370HM2 294814HM9 294817HM2 308912HM5 308926HM5 309479HM4 309482HM8 309491HM9 309494HM3 309497HM6 309500HM7 309503HM1 310697HM8 310700HM0 310703HM4 310706HM7 310709HM1 310712HM5 310715HM8 310718HM2 310721HM6 310724HM0 311119HM2 311122HM6 311125HM9 312210HM8 312213HM2 312216HM5 312219HM9 312222HM3 312225HM6 312228HM0 312349HM4 312352HM8 312355HM1 312358HM5 312361HM9 312364HM3 312367HM6 199950HM7 205562HM2 171317HM1 236450HM3 271730HM4 297309HM7 252405HM6 256430HM0 256455HM7 250045HM2 257786HM4 256147HM0 290021HM5 269450HM3 271712HM2 271718HM9 274227HM8 213022HM7 185947HM9 185369HM6 191521HM4 285908HM0 257543HM9 259651HM8 289383HM2 290006HM6 294364HM5 286895HM8 267649HM2 268806HM7 282407HM6 286652HM3 286877HM6 269444HM6 284469HM4 289978HM9 267640HM1 276189HM8 280562HM0 177222HM7 172802HM1 166315HM2 168297HM0 224432HM5 259738HM3 270004HM5 262313HM0 282410HM0 281222HM0 257549HM6 221033HM4 170572HM2 301813HM2 302725HM7 305839HM3 163410HM4 184411HM7 186185HM5 208913HM4 266888HM7 262307HM2 301929HM6 271727HM0 278696HM0 295714HM0 291212HM9 290027HM2 281446HM5 301932HM0 306317HM9 308535HM4 176776HM3 266891HM1 271414HM5 189107HM6 208937HM3 252399HM1 263679HM3 160222HM6 259660HM9 195460HM1 205666HM1 257825HM0 269412HM3 259666HM6 183780HM6 302710HM9 195287HM8 208285HM7 219747HM3 220369HM3 247222HM3 257835HM9 271709HM8 276195HM5 181957HM2 184081HM8 188801HM5 199883HM0 219988HM3 234932HM2 262316HM3 262301HM5 221645HM5 182786HM4 223171HM0 290000HM9 214718HM9 284478HM5 269415HM6 255972HM2 286883HM4 214477HM2 227440HM5 195590HM5 267637HM7 278681HM2 293797HM7 262292HM6 174879HM7 210062HM6 268815HM8 284472HM8 276186HM4 295711HM6 305315HM4 308523HM0 166009HM1 169411HM6 220560HM7 266909HM1 256427HM6 302731HM5 297312HM1 264995HM2 195286HM0 223710HM5 231594HM3 233074HM4 234970HM2 231164HM5 269434HM7 270507HM7 276183HM1 267661HM7 291781HM3 177221HM9 178471HM9 183327HM6 312428HM6
Product Distributed Qty 864 (57 US; 802 OUS)
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 reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.

Event Detail

Event Id 64918
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.