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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
Recall Number Z-0725-2014
Classification Class II
Code Info Serial Numbers: 00000002796EN1, 00000002797EN9, 00000002798EN7, 00000002799EN5, 00000002800EN1, 00000002801EN9, 00000102726WK9, 00000102789WK3, Serial Numbers: 00000002796EN1, 00000002797EN9, 00000002798EN7, 00000002799EN5, 00000002800EN1, 00000002801EN9, 00000102726WK9, 00000102789WK3, 00000102937WK7, 00000130778WK3, 00000UA45526-8, 00001027058WK5, 00001027061WK9, 00001027146WK8, 00001027149WK2, 00001027150WK0, 00001027151WK8, 00001027153WK4, 00001027154WK2, 00001027167WK4, 00001027168WK2, 00001027169WK0, 00001027175WK7, 00001027193WK0, 00001027194WK8, 00001027195WK5, 00001027199WK7, 00001027200WK3, 00001027203WK7, 00001027204WK5, 00001027207WK8, 00001027214WK4, 00001027256WK5, 00001027259WK9, 00001027260WK7, 00001027262WK3, 00001027264WK9, 00001027265WK6, 00001027267WK2, 00001027268WK0, 00001027269WK8, 00001027276WK3, 00001027277WK1, 00001027278WK9, 00001027280WK5, 00001027293WK8, 00001027294WK6, 00001027295WK3, 00001027297WK9, 00001027298WK7, 00001027299WK5, 00001027300WK1, 00001027301WK9, 00001027302WK7, 00001027303WK5, 00001027314WK2, 00001027318WK3, 00001027322WK5, 00001027323WK3, 00001027324WK1, 00001027325WK8, 00001027326WK6, 00001027344WK9, 00001027346WK4, 00001027347WK2, 00001027349WK8, 00001027350WK6, 00001027351WK4, 00001027352WK2, 00001027353WK0, 00001027354WK8, 00001027356WK3, 00001027359WK7, 00001027362WK1, 00001027363WK9, 00001027364WK7, 00001027369WK6, 00001027371WK2, 00001027372WK0, 00001027373WK8, 00001027374WK6, 00001027376WK1, 00001027377WK9, 00001027380WK3, 00001027382WK9, 00001027383WK7, 00001027384WK5, 00001027386WK0, 00001027387WK8, 00001027388WK6, 00001027389WK4, 00001027390WK2, 00001027406WK6, 00001027407WK4, 00001027416WK5, 00001027417WK3, 00001027418WK1, 00001027421WK5, 00001027422WK3, 00001027423WK1, 00001027438WK9, 00001027445WK4, 00001027450WK4, 00001027451WK2, 00001027452WK0, 00001027464WK5, 00001027465WK2, 00001027466WK0, 00001027487WK6, 00001027488WK4, 00001027489WK2, 00001027490WK0, 00001027506WK3, 00001027507WK1, 00001027508WK9, 00001027539WK4, 00001027540WK2, 00001027541WK0, 00001027542WK8, 00001027543WK6, 00001027544WK4, 00001027551WK9, 00001027552WK7, 00001027553WK5, 00001027582WK4, 00001027583WK2, 00001027699WK6, 00001027700WK2, 00001027736WK6, 00001027737WK4, 00001027749WK9, 00001027762WK2, 00001027764WK8, 00001027765WK5, 00001027766WK3, 00001027768WK9, 00001027769WK7, 00001027772WK1, 00001027773WK9, 00001027774WK7, 00001027775WK4, 00001027778WK8, 00001027779WK6, 00001027781WK2, 00001027814WK1, 00001027819WK0, 00001027820WK8, 00001027821WK6, 00001027823WK2, 00001027824WK0, 00001027825WK7, 00001027826WK5, 00001027827WK3, 00001027828WK1, 00001027878WK6, 00001027880WK2, 00001027887WK7, 00001027888WK5, 00001027889WK3, 00001027890WK1, 00001027891WK9, 00001027892WK7, 00001027893WK5, 00001027894WK3, 00001027895WK0, 00001027896WK8, 00001027915WK6, 00001027932WK1, 00001027934WK7, 00001027935WK4, 00001027939WK6, 00001027992WK5, 00001027993WK3, 00001027994WK1, 00001027995WK8, 00001027996WK6, 00001028003WK0, 00001028021WK2, 00001028022WK0, 00001028023WK8, 00001028025WK3, 00001028035WK2, 00001028036WK0, 00001028042WK8, 00001028043WK6, 00001028044WK4, 00001028050WK1, 00001028051WK9, 00001028052WK7, 00001028053WK5, 00001028064WK2, 00001028065WK9, 00001028066WK7, 00001028077WK4, 00001028078WK2, 00001028079WK0, 00001028080WK8, 00001028091WK5, 00001028092WK3, 00001028093WK1, 00001028094WK9, 00001028119WK4, 00001028120WK2, 00001028205WK1, 00001028213WK5, 00001028214WK3, 00001028215WK0, 00001028216WK8, 00001028217WK6, 00001028230WK9, 00001028231WK7, 00001028232WK5, 00001028267WK1, 00001028269WK7, 00001028275WK4, 00001028276WK2, 00001028277WK0, 00001028279WK6, 00001028280WK4, 00001028281WK2, 00001028283WK8, 00001028284WK6, 00001028285WK3, 00001028286WK1, 00001028287WK9, 00001028288WK7, 00001028289WK5, 00001028290WK3, 00001028291WK1, 00001028292WK9, 00001028294WK5, 00001028331WK5, 00001028333WK1, 00001028334WK9, 00001028337WK2, 00001028338WK0, 00001028339WK8, 00001028340WK6, 00001028341WK4, 00001028342WK2, 00001028343WK0, 00001028344WK8, 00001028345WK5, 00001028346WK3, 00001028347WK1, 00001028351WK3, 00001028352WK1, 00001028353WK9, 00001028354WK7, 00001028363WK8, 00001028365WK3, 00001028369WK5, 00001028370WK3, 00001028396WK8, 00001028397WK6, 00001028398WK4, 00001028399WK2, 00001028464WK4, 00001028465WK1, 00001028467WK7, 00001028468WK5, 00001028469WK3, 00001028470WK1, 00001028471WK9, 00001028472WK7, 00001028476WK8, 00001028477WK6, 00001028478WK4, 00001028501WK3, 00001028502WK1, 00001028503WK9, 00001028505WK4, 00001028506WK2, 00001028517WK9, 00001028518WK7, 00001028519WK5, 00001028520WK3, 00001028522WK9, 00001028523WK7, 00001028524WK5, 00001028536WK9, 00001028537WK7, 00001028538WK5, 00001028539WK3, 00001028559WK1, 00001028560WK9, 00001028561WK7, 00001028562WK5, 00001028563WK3, 00001028574WK0, 00001028575WK7, 00001028576WK5, 00001028605WK2, 00001028617WK7, 00001028621WK9, 00001028680WK5, 00001028681WK3, 00001028682WK1, 00001028683WK9, 00001028685WK4, 00001028686WK2, 00001028687WK0, 00001028688WK8, 00001028689WK6, 00001028690WK4, 00001028691WK2, 00001028692WK0, 00001028693WK8, 00001028694WK6, 00001028695WK3, 00001028716WK7, 00001028717WK5, 00001028718WK3, 00001028719WK1, 00001028799WK3, 00001028800WK9, 00001028801WK7, 00001028802WK5, 00001028803WK3, 00001028850WK4, 00001028851WK2, 00001028852WK0, 00001028853WK8, 00001028854WK6, 00001028855WK3, 00001028856WK1, 00001028857WK9, 00001028858WK7, 00001028859WK5, 00001028889WK2, 00001028890WK0, 00001028891WK8, 00001028895WK9, 00001028896WK7, 00001028897WK5, 00001028898WK3, 00001028899WK1, 00001028900WK7, 00001028901WK5, 00001028902WK3, 00001028916WK3, 00001028917WK1, 00001028977WK5, 00001028979WK1, 00001028980WK9, 00001028982WK5, 00001028983WK3, 00001028984WK1, 00001028985WK8, 00001028986WK6, 00001028989WK0, 00001028990WK8, 00001028991WK6, 00001028992WK4, 00001028993WK2, 00001028994WK0, 00001028995WK7, 00001028996WK5, 00001028997WK3, 00001028998WK1, 00001029036WK9, 00001029037WK7, 00001029038WK5, 00001029039WK3, 00001029040WK1, 00001029041WK9, 00001029042WK7, 00001029043WK5, 00001029044WK3, 00001029046WK8, 00001029048WK4, 00001029049WK2, 00001029050WK0, 00001029051WK8, 00001029052WK6, 00001029053WK4, 00001029054WK2, 00001029055WK9, 00001029062WK5, 00001029066WK6, 00001029067WK4, 00001029068WK2, 00001029069WK0, 00001029070WK8, 00001029159WK9, 00001029160WK7, 00001029161WK5, 00001029162WK3, 00001029163WK1, 00001029212WK6, 00001029220WK9, 00001029366WK0, 00001029373WK6, 00001029374WK4, 00001029375WK1, 00001029376WK9, 00001029378WK5, 00001029442WK9, 00001029443WK7, 00001029444WK5, 00001029446WK0, 00001029460WK1, 00001029461WK9, 00001029462WK7, 00001029464WK3, 00001029465WK0, 00001029472WK6, 00001029473WK4, 00001029475WK9, 00001029476WK7, 00001029521WK0, 00001029523WK6, 00001029539WK2, 00001029540WK0, 00001029541WK8, 00001029542WK6, 00001029543WK4, 00001029544WK2, 00001029545WK9, 00001029546WK7, 00001029566WK5, 00001029567WK3, 00001029568WK1, 00001029569WK9, 00001029570WK7, 00001029571WK5, 00001029572WK3, 00001029573WK1, 00001029574WK9, 00001029575WK6, 00001029592WK1, 00001029593WK9, 00001029594WK7, 00001029595WK4, 00001029597WK0, 00001029598WK8, 00001029614WK3, 00001029615WK0, 00001029616WK8, 00001029620WK0, 00001029621WK8, 00001029622WK6, 00001029625WK9, 00001029626WK7, 00001029628WK3, 00001029630WK9, 00001029631WK7, 00001029632WK5, 00001029635WK8, 00001029636WK6, 00001029639WK0, 00001029640WK8, 00001029641WK6, 00001029642WK4, 00001029643WK2, 00001029649WK9, 00001029650WK7, 00001029651WK5, 00001029652WK3, 00001029653WK1, 00001029654WK9, 00001029655WK6, 00001029656WK4, 00001029657WK2, 00001029658WK0, 00001029674WK7, 00001029675WK4, 00001029676WK2, 00001029677WK0, 00001029678WK8, 00001029679WK6, 00001029681WK2, 00001029683WK8, 00001029684WK6, 00001029685WK3, 00001029693WK7, 00001029694WK5, 00001029695WK2, 00001029696WK0, 00001029697WK8, 00001029698WK6, 00001029699WK4, 00001029700WK0, 00001029701WK8, 00001029702WK6, 00001029724WK0, 00001029725WK7, 00001029726WK5, 00001029727WK3, 00001029728WK1, 00001029729WK9, 00001029733WK1, 00001029734WK9, 00001029735WK6, 00001029736WK4, 00001029737WK2, 00001029738WK0, 00001029739WK8, 00001029740WK6, 00001029741WK4, 00001029742WK2, 00001029743WK0, 00001029744WK8, 00001029745WK5, 00001029746WK3, 00001029747WK1, 00001029755WK4, 00001029756WK2, 00001029758WK8, 00001029759WK6, 00001029762WK0, 00001029763WK8, 00001029764WK6, 00001029766WK1, 00001029767WK9, 00001029768WK7, 00001029769WK5, 00001029770WK3, 00001029786WK9, 00001029787WK7, 00001029796WK8, 00001029797WK6, 00001029804WK0, 00001029813WK1, 00001029814WK9, 00001029820WK6, 00001029821WK4, 00001029825WK5, 00001029826WK3, 00001029827WK1, 00001029828WK9, 00001029861WK0, 00001029862WK8, 00001029863WK6, 00001029864WK4, 00001029865WK1, 00001029868WK5, 00001029869WK3, 00001029870WK1, 00001029885WK9, 00001029886WK7, 00001029887WK5, 00001029888WK3, 00001029889WK1, 00001029890WK9, 00001029900WK6, 00001029901WK4, 00001029902WK2, 00001029903WK0, 00001029931WK1, 00001029932WK9, 00001029933WK7, 00001029934WK5, 00001029935WK2, 00001029941WK0, 00001029948WK5, 00001029949WK3, 00001029950WK1, 00001029951WK9, 00001029952WK7, 00001029953WK5, 00001029954WK3, 00001029955WK0, 00001029956WK8, 00001029959WK2, 00001029960WK0, 00001029961WK8, 00001029962WK6, 00001029963WK4, 00001029969WK1, 00001029970WK9, 00001029973WK3, 00001029974WK1, 00001030002WK8, 00001030003WK6, 00001030004WK4, 00001030008WK5, 00001030009WK3, 00001030010WK1, 00001030011WK9, 00001030012WK7, 00001030025WK9, 00001030026WK7, 00001030027WK5, 00001030028WK3, 00001030029WK1, 00001030031WK7, 00001030032WK5, 00001030033WK3, 00001030035WK8, 00001030045WK7, 00001030046WK5, 00001030049WK9, 00001030050WK7, 00001030052WK3, 00001030054WK9, 00001030057WK2, 00001030065WK5, 00001030075WK4, 00001030082WK0, 00001030206WK5, 00001030210WK7, 00001030211WK5, 00001030212WK3, 00001030216WK4, 00001030217WK2, 00001030218WK0, 00001030219WK8, 00001030235WK4, 00001030236WK2, 00001030239WK6, 00001030240WK4, 00001030241WK2, 00001030242WK0, 00001030243WK8, 00001030269WK3, 00001030270WK1, 00001030271WK9, 00001030272WK7, 00001030273WK5, 00001030284WK2, 00001030285WK9, 00001030286WK7, 00001030287WK5, 00001030288WK3, 00001030289WK1, 00001030290WK9, 00001030291WK7, 00001030292WK5, 00001030293WK3, 00001030366WK7, 00001030367WK5, 00001030368WK3, 00001030369WK1, 00001030371WK7, 00001030406WK1, 00001030407WK9, 00001030408WK7, 00001030432WK7, 00001030433WK5, 00001030437WK6, 00001030438WK4, 00001030510WK0, 00001030511WK8, 00001030512WK6, 00001030513WK4, 00001030514WK2, 00001030531WK6, 00001030532WK4, 00001030533WK2, 00001030534WK0, 00001030535WK7, 00001030536WK5, 00001030537WK3, 00001030538WK1, 00001030539WK9, 00001030540WK7, 00001030557WK1, 00001030558WK9, 00001030559WK7, 00001030560WK5, 00001030561WK3, 00001030562WK1, 00001030585WK2, 00001030586WK0, 00001030587WK8, 00001030588WK6, 00001030589WK4, 00001030590WK2, 00001030591WK0, 00001030592WK8, 00001030593WK6, 00001030594WK4, 00001030595WK1, 00001030596WK9, 00001030597WK7, 00001030598WK5, 00001030602WK5, 00001030603WK3, 00001030604WK1, 00001030605WK8, 00001030606WK6, 00001030607WK4, 00001030617WK3, 00001030618WK1, 00001030619WK9, 00001030627WK2, 00001030628WK0, 00001030636WK3, 00001030637WK1, 00001030638WK9, 00001030654WK6, 00001030655WK3, 00001030656WK1, 00001030657WK9, 00001030660WK3, 00001030661WK1, 00001030669WK4, 00001030671WK0, 00001030672WK8, 00001030673WK6, 00001030674WK4, 00001030675WK1, 00001030736WK1, 00001030737WK9, 00001030738WK7, 00001030743WK7, 00001030744WK5, 00001030759WK3, 00001030760WK1, 00001030761WK9, 00001030762WK7, 00001030763WK5, 00001030775WK9, 00001030776WK7, 00001030777WK5, 00001030778WK3, 00001030779WK1, 00001030780WK9, 00001030781WK7, 00001030782WK5, 00001030791WK6, 00001030792WK4, 00001030793WK2, 00001030794WK0, 00001030795WK7, 00001030796WK5, 00001030797WK3, 00001030799WK9, 00001030800WK5, 00001030801WK3, 00001030802WK1, 00001030803WK9, 00001030804WK7, 00001030805WK4, 00001030806WK2, 00001030807WK0, 00001030808WK8, 00001030809WK6, 00001030810WK4, 00001030811WK2, 00001030812WK0, 00001030813WK8, 00001030814WK6, 00001030815WK3, 00001030816WK1, 00001030839WK3, 00001030840WK1, 00001030841WK9, 00001030842WK7, 00001030843WK5, 00001030844WK3, 00001030845WK0, 00001030846WK8, 00001030847WK6, 00001030849WK2, 00001030850WK0, 00001030854WK2, 00001030856WK7, 00001030899WK7, 00001030900WK3, 00001030901WK1, 00001030903WK7, 00001030904WK5, 00001030905WK2, 00001030907WK8, 00001030908WK6, 00001030909WK4, 00001030915WK1, 00001030916WK9, 00001030917WK7, 00001030918WK5, 00001030919WK3, 00001030920WK1, 00001030921WK9, 00001030922WK7, 00001030925WK0, 00001030926WK8, 00001030928WK4, 00001030929WK2, 00001030930WK0, 00001030950WK8, 00001030951WK6, 00001030952WK4, 00001030953WK2, 00001030954WK0, 00001030955WK7, 00001030956WK5, 00001030957WK3, 00001030958WK1, 00001030959WK9, 00001030960WK7, 00001030962WK3, 00001030963WK1, 00001030964WK9, 00001030993WK8, 00001030994WK6, 00001030995WK3, 00001031006WK8, 00001031007WK6, 00001031008WK4, 00001031009WK2, 00001031010WK0, 00001031011WK8, 00001031012WK6, 00001031013WK4, 00001031014WK2, 00001031017WK5, 00001031018WK3, 00001031019WK1, 00001031020WK9, 00001031021WK7, 00001031028WK2, 00001031029WK0, 00001031031WK6, 00001031032WK4, 00001031033WK2, 00001031053WK0, 00001031054WK8, 00001031055WK5, 00001031058WK9, 00001031059WK7, 00001031060WK5, 00001031061WK3, 00001031062WK1, 00001031063WK9, 00001031064WK7, 00001031108WK2, 00001031109WK0, 00001031110WK8, 00001031111WK6, 00001031112WK4, 00001031113WK2, 00001031116WK5, 00001031117WK3, 00001031118WK1, 00001031119WK9, 00001031120WK7, 00001031121WK5, 00001031122WK3, 00001031123WK1, 00001031124WK9, 00001031125WK6, 00001031153WK8, 00001031154WK6, 00001031155WK3, 00001031156WK1, 00001031157WK9, 00001031158WK7, 00001031166WK0, 00001031167WK8, 00001031168WK6, 00001031169WK4, 00001031170WK2, 00001031172WK8, 00001031173WK6, 00001031174WK4, 00001031175WK1, 00001031176WK9, 00001031177WK7, 00001031178WK5, 00001031179WK3, 00001031181WK9, 00001031206WK4, 00001031207WK2, 00001031208WK0, 00001031213WK0, 00001031214WK8, 00001031215WK5, 00001031215WK5, 00001031216WK3, 00001031219WK7, 00001031220WK5, 00001031221WK3, 00001031222WK1, 00001031226WK2, 00001031227WK0, 00001031228WK8, 00001031229WK6, 00001031235WK3, 00001031238WK7, 00001031239WK5, 00001031246WK0, 00001031247WK8, 00001031248WK6, 00001031249WK4, 00001031250WK2, 00001031251WK0, 00001031281WK7, 00001031282WK5, 00001031283WK3, 00001031284WK1, 00001031286WK6, 00001031287WK4, 00001031332WK8, 00001031334WK4, 00001031335WK1, 00001031336WK9, 00001031337WK7, 00001031338WK5, 00001031339WK3, 00001031341WK9, 00001031342WK7, 00001031343WK5, 00001031350WK0, 00001031351WK8, 00001031352WK6, 00001031353WK4, 00001031361WK7, 00001031362WK5, 00001031363WK3, 00001031386WK4, 00001031387WK2, 00001031389WK8, 00001031390WK6, 00001031391WK4, 00001031392WK2, 00001031401WK1, 00001031402WK9, 00001031403WK7, 00001031408WK6, 00001031413WK6, 00001031414WK4, 00001031415WK1, 00001031416WK9, 00001031457WK3, 00001031458WK1, 00001031459WK9, 00001031460WK7, 00001031461WK5, 00001031462WK3, 00001031464WK9, 00001031465WK6, 00001031466WK4, 00001031467WK2, 00001031468WK0, 00001031479WK7, 00001031480WK5, 00001031481WK3, 00001031483WK9, 00001031484WK7, 00001031490WK4, 00001031491WK2, 00001031492WK0, 00001031493WK8, 00001031495WK3, 00001031496WK1, 00001031506WK7, 00001031507WK5, 00001031508WK3, 00001031510WK9, 00001031511WK7, 00001031512WK5, 00001031515WK8, 00001031516WK6, 00001031517WK4, 00001031518WK2, 00001031519WK0, 00001031520WK8, 00001031521WK6, 00001031522WK4, 00001031523WK2, 00001031524WK0, 00001031525WK7, 00001031537WK2, 00001031538WK0, 00001031539WK8, 00001031566WK1, 00001031567WK9, 00001031568WK7, 00001031569WK5, 00001031570WK3, 00001031571WK1, 00001031572WK9, 00001031573WK7, 00001031574WK5, 00001031581WK0, 00001031649WK5, 00001031650WK3, 00001031651WK1, 00001031652WK9, 00001031653WK7, 00001031654WK5, 00001031655WK2, 00001031656WK0, 00001031657WK8, 00001031658WK6, 00001031659WK4, 00001031660WK2, 00001031661WK0, 00001031662WK8, 00001031665WK1, 00001031666WK9, 00001031667WK7, 00001031669WK3, 00001031670WK1, 00001031671WK9, 00001031672WK7, 00001031673WK5, 00001031674WK3, 00001031675WK0, 00001031676WK8, 00001031677WK6, 00001031699WK0, 00001031700WK6, 00001031702WK2, 00001031703WK0, 00001031704WK8, 00001031705WK5, 00001031706WK3, 00001031711WK3, 00001031712WK1, 00001031728WK7, 00001031729WK5, 00001031730WK3, 00001031733WK7, 00001031734WK5, 00001031735WK2, 00001031738WK6, 00001031739WK4, 00001031740WK2, 00001031749WK3, 00001031750WK1, 00001031751WK9, 00001031752WK7, 00001031810WK3, 00010299771WK7.
Product Distributed Qty 1027
Reason For Recall There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile x-ray system are not properly displayed. If the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam/patient.

Event Detail

Event Id 67136
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including Washington D.C., and Guam and the countries of ALBANIA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA , COLOMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAQ, IRELAND, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, NIGERIA, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
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