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U.S. Department of Health and Human Services

Class 2 Device Recall LOGIQ S8 and LOGIQ S7 Ultrasound System

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 Class 2 Recall
LOGIQ S8 and LOGIQ S7 Ultrasound System
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Date Posted April 11, 2013
Recall Status1 Terminated on November 21, 2013
Recall Number Z-1096-2013
Recall Event ID 64725
Premarket Notification
510(K) Numbers
K111582  K122114 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.
Code Information Mfg Lot or Serial # 176132SU9 176138SU6 178028SU7 158247SU7 172656SU1 187599SU6 201614SU5 201615SU2 195234SU0 195237SU3 161686SU1 203123SU5 170272SU9 189160SU5 189162SU1 170273SU7 185619SU4 176924SU9 191894SU5 159964SU6 159768SU1 170197SU8 158248SU5 171540SU8 171541SU6 160741SU5 160742SU3 160743SU1 159766SU5 197761SU0 198949SU0 195241SU5 189928SU5 164268SU5 159963SU8 185116SU1 195242SU3 201967SU7 166218SU8 185968SU5 189165SU4 189166SU2 189167SU0 189168SU8 189169SU6 195235SU7 195236SU5 171371SU8 168779SU7 189163SU9 190393SU9 159767SU3 167274SU0 201464SU5 195233SU2 171369SU2 177085SU8 186501SU3 171370SU0 187022SU9 191063SU7 185969SU3 168788SU8 159965SU3 201612SU9 159604SU8 178592SU2 178593SU0 178594SU8 178595SU5 185620SU2 185621SU0 176926SU4 176925SU6 191893SU7 177084SU1 192952SU0 195238SU1 195239SU9 195240SU7 201971SU9 201972SU7 202046SU9 195881SU8 186579SU9 204275SU2 171542SU4 171947SU5 192951SU2 201906SU5 204921SU1 204922SU9 204923SU7 204924SU5 204925SU2 189161SU3 181434SU2 158768SU2 183107SU2 166181SU8 169509SU7 170671SU2 187015SU3 187014SU6 183118SU9 170672SU0 176130SU3 182380SU6 188131SU7 188121SU8 159776SU4 159792SU1 191471SU2 182223SU8 182222SU0 183104SU9 166172SU7 197249SU6 194194SU7 168080SU0 195876SU8 198407SU9 190385SU5 190754SU2 190390SU5 182654SU4 182655SU1 182656SU9 189924SU4 176566SU8 176567SU6 190752SU6 190753SU4 194561SU7 194562SU5 194563SU3 194564SU1 194565SU8 196258SU8 183907SU5 200715SU1 188545SU8 176939SU7 190505SU8 190506SU6 190507SU4 192947SU0 180973SU0 183102SU3 176938SU9 185798SU6 200709SU4 180363SU4 183660SU0 183661SU8 189354SU4 202264SU8 192059SU4 192060SU2 192116SU2 192115SU4 193638SU4 199071SU2 192120SU4 183470SU4 183471SU2 183472SU0 183473SU8 186887SU6 192058SU6 192061SU0 192062SU8 192063SU6 192065SU1 192105SU5 192110SU5 192114SU7 192119SU6 192546SU0 192547SU8 192548SU6 192549SU4 192550SU2 192551SU0 192552SU8 192553SU6 193342SU3 194554SU2 196884SU1 196885SU8 197658SU8 197760SU2 198879SU9 199237SU9 199238SU7 199239SU5 200704SU5 200706SU0 200717SU7 201237SU5 201238SU3 201239SU1 201616SU0 201617SU8 201907SU3 201965SU1 201966SU9 202262SU2 202263SU0 202265SU5 202266SU3 202267SU1 202494SU1 202495SU8 202496SU6 202497SU4 202498SU2 202725SU8 202732SU4 203033SU6 192118SU8 192064SU4 200173SU3 192113SU9 192112SU1 192106SU3 194555SU9 192117SU0 192107SU1 192111SU3 200409SU1 193344SU9 182653SU6 194542SU7 190400SU2 190396SU2 190380SU6 190391SU3 194537SU7 194540SU1 194538SU5 190395SU4 190399SU6 190387SU1 190384SU8 190388SU9 190382SU2 189691SU9 183912SU5 159246SU8 198930SU0 198931SU8 198932SU6 189693SU5 191015SU7 194182SU2 187011SU2 191016SU5 193903SU2 158805SU2 180762SU7 197254SU6 170669SU6 198929SU2 183920SU8 170679SU5 170683SU7 158802SU9 162595SU3 185297SU9 194190SU5 182379SU8 176132SU9 183108SU0 168063SU6 168064SU4 169487SU6 169506SU3 191567SU7 192568SU4 176121SU2 158806SU0 195863SU6 195864SU4 195865SU1 195872SU7 201236SU7 183922SU4 185294SU6 187597SU0 159784SU8 186590SU6 196272SU9 185302SU7 185305SU0 188124SU2 165587SU7 168058SU6 191562SU8 170676SU1 198947SU4 162594SU6 163224SU9 198924SU3 198926SU8 159789SU7 191563SU6 198940SU9 198941SU7 183913SU3 183914SU1 198910SU2 198911SU0 185301SU9 198945SU8 182227SU9 178022SU0 178023SU8 198424SU4 158800SU3 191564SU4 165585SU1 168056SU0 191013SU2 182228SU7 182376SU4 191560SU2 198946SU6 183105SU6 197256SU1 187598SU8 168068SU5 170675SU3 198921SU9 185307SU6 165588SU5 175622SU0 175623SU8 168070SU1 180761SU9 182382SU2 191014SU0 201235SU9 176136SU0 189175SU3 198922SU7 198923SU5 159782SU2 159783SU0 168057SU8 182230SU3 183106SU4 185299SU5 185304SU3 182378SU0 187596SU2 198919SU3 198920SU1 168060SU2 198925SU0 185295SU3 198943SU3 198944SU1 163225SU6 183109SU8 183110SU6 198939SU1 168059SU4 188128SU3 185300SU1 166185SU9 185306SU8 178018SU8 183918SU2 183921SU6 170674SU6 201444SU7 161687SU9 161688SU7 161689SU5 161690SU3 161691SU1 161692SU9 189176SU1 198942SU5 189172SU0 159788SU9 187594SU7 187595SU4 197255SU3 189173SU8 198915SU1 165584SU4 176135SU2 201439SU7 165583SU6 165586SU9 182377SU2 162593SU8 191561SU0 196259SU6 198948SU2 195871SU9 198099SU4 199010SU0 168073SU5 168074SU3 168075SU0 168071SU9 159778SU0 175624SU6 187591SU3 191544SU6 178027SU9 181605SU7 166178SU4 194528SU6 183120SU5 178026SU1 171946SU7 182224SU6 170897SU3 198897SU1 178016SU2 183915SU8 194535SU1 199497SU9 169502SU2 169508SU9 185308SU4 186451SU1 178029SU5 158763SU3 180768SU4 161694SU5 176138SU6 159249SU2 159249SU2 183116SU3 159775SU6 162598SU7 190405SU1 190406SU9 171944SU2 185292SU0 163230SU6 163223SU1 158759SU1 158766SU6 175617SU0 196271SU1 183911SU7 194187SU1 196268SU7 193954SU5 166176SU8 166177SU6 166174SU3 168055SU2 170673SU8 166180SU0 187018SU7 185303SU5 189180SU3 159247SU6 191466SU2 180763SU5 194186SU3 191543SU8 183113SU0 183114SU8 183115SU5 201441SU3 168838SU1 170898SU1 158767SU4 162599SU5 201443SU9 188120SU0 159779SU8 191558SU6 169511SU3 178038SU6 166183SU4 196264SU6 191549SU5 182221SU2 201446SU2 168072SU7 184258SU2 186588SU0 194526SU0 159781SU4 169505SU5 190410SU1 176128SU7 159785SU5 159786SU3 178019SU6 178020SU4 192954SU6 192956SU1 194544SU3 201442SU1 162597SU9 196263SU8 169493SU4 194534SU4 159793SU9 178017SU0 183910SU9 169510SU5 185291SU2 171945SU9 193960SU2 190401SU0 192955SU3 169513SU9 178025SU3 191554SU5 168076SU8 165595SU0 187008SU8 187588SU9 191550SU3 159777SU2 169503SU0 176131SU1 169504SU8 193904SU0 183888SU7 166179SU2 163229SU8 198933SU4 163231SU4 180765SU0 199496SU1 189183SU7 181433SU4 193963SU6 159774SU9 162596SU1 166175SU0 196266SU1 191465SU4 191679SU0 193964SU4 187021SU1 194527SU8 198427SU7 188119SU2 183926SU5 190403SU6 190404SU4 197259SU5 198436SU8 191463SU9 197169SU6 197240SU5 198101SU8 197173SU8 195858SU6 197242SU1 198323SU8 197172SU0 198317SU0 197170SU4 198322SU0 197243SU9 190381SU4 201226SU8 198100SU0 178028SU7 198321SU2 195875SU0 198316SU2 198406SU1 198098SU6 191545SU3 172890SU6 198928SU4 183119SU7 161695SU2 176015SU6 158764SU1 189674SU5 193952SU9 170681SU1 184445SU5 189440SU1 189441SU9 202470SU1 202492SU5 202493SU3 179387SU6 179388SU4 200718SU5 165598SU4 176013SU1 159248SU4 191547SU9 186399SU2 159244SU3 183908SU3 158807SU8 165599SU2 159251SU8 183916SU6 190407SU7 181431SU8 182381SU4 176122SU0 165590SU1 183917SU4 165589SU3 193900SU8 188132SU5 165600SU8 170894SU0 191546SU1 158760SU9 169501SU4 187010SU4 178021SU2 176127SU9 198934SU2 187585SU5 187012SU0 165591SU9 165592SU7 165593SU5 165594SU3 170895SU7 193902SU4 194181SU4 171942SU6 175618SU8 168053SU7 187013SU8 170896SU5 183924SU0 183925SU7 198408SU7 199014SU2 198405SU3 183112SU2 197171SU2 159951SU3 192701SU1 153258SU9 195256SU3 196255SU4 192122SU0 192121SU2 192706SU0 193643SU4 181309SU6 153255SU5 159953SU9 174785SU6 180006SU9 159956SU2 175346SU6 159241SU9 164232SU1 196256SU2 192702SU9 159601SU4 158245SU1 171935SU0 196881SU7 196882SU5 168784SU7 188593SU8 188594SU6 188595SU3 176444SU8 168782SU1 176443SU0 188596SU1 162831SU2 196253SU9 200712SU8 159954SU7 195713SU3 188598SU7 192125SU3 172855SU9 176440SU6 190755SU9 199241SU1 159957SU0 175348SU2 176445SU5 188591SU2 164237SU0 162830SU4 180365SU9 192705SU2 180005SU1 181308SU8 181308SU8 199076SU1 159948SU9 159949SU7 173818SU6 176447SU1 164238SU8 195710SU9 188597SU9 175349SU0 153260SU5 153254SU8 193639SU2 176441SU4 192127SU9 195209SU2 166279SU0 167283SU1 166275SU8 167282SU3 166283SU2 167285SU6 166276SU6 166278SU2 167277SU3 167284SU9 167286SU4 167278SU1 166280SU8 166281SU6 166282SU4 167279SU9 167280SU7 167281SU5 166277SU4 164233SU9 175347SU4 182385SU5 182435SU8 175350SU8 181312SU0 180000SU2 162832SU0 200711SU0 159608SU9 195712SU5 180366SU7 195259SU7 168787SU0 192703SU7 168786SU2 174784SU9 193641SU8 193642SU6 164239SU6 164240SU4 174781SU5 153256SU3 196878SU3 196880SU9 195711SU7 195255SU5 168783SU9 199072SU0 159602SU2 159605SU5 181314SU6 164236SU2 190758SU3 190756SU7 164235SU4 168781SU3 199244SU5 190757SU5 164234SU7 196275SU2 196276SU0 196277SU8 196278SU6 183468SU8 200340SU8 201465SU2 195714SU1 180004SU4 171934SU3 178952SU8 171933SU5 159947SU1 196257SU0 171931SU9 178954SU4 199075SU3 188592SU0 174782SU3 174783SU1 176442SU2 158244SU4 192707SU8 200342SU4 200714SU4 153257SU1 176446SU3 168780SU5 183469SU6 193640SU0 195257SU1 159950SU5 159603SU0 159596SU6 178953SU6 182388SU9 180367SU5 182384SU8 159952SU1 171936SU8 172853SU4 172854SU2 173816SU0 173817SU8 190759SU1 182436SU6 159600SU6 179999SU8 181313SU8 200344SU0 153259SU7 159599SU0 159607SU1 159955SU4 159959SU6 159960SU4 159961SU2 162833SU8 162834SU6 171932SU7 173819SU4 180001SU0 180002SU8 180003SU6 181310SU4 182233SU7 182234SU5 182235SU2 182386SU3 182387SU1 192126SU1 192128SU7 192129SU5 192130SU3 192131SU1 192132SU9 192133SU7 192704SU5 195208SU4 195210SU0 195212SU6 195213SU4 195214SU2 195215SU9 195216SU7 195217SU5 195218SU3 195219SU1 195220SU9 195221SU7 195222SU5 195223SU3 195223SU3 195258SU9 196254SU7 196274SU5 196879SU1 202259SU8 203284SU5 159597SU4 159962SU0 158243SU6 159958SU8 159242SU7 164241SU2 168785SU4 192123SU8 192124SU6 195211SU8 199242SU9 203280SU3 203282SU9 203283SU7 159598SU2 159606SU3 180364SU2 199073SU8 200713SU6 202258SU0 202260SU6 202261SU4 204265SU3 204266SU1 204267SU9 204268SU7 203281SU1 199240SU3 199243SU7 200341SU6 200343SU2 201072SU6 201073SU4 201074SU2 201075SU9 201076SU7 201973SU5 201974SU3 201975SU0 201976SU8 201977SU6 202257SU2 199074SU6 185457SU9 193385SU2 193386SU0 193387SU8 197759SU4 200710SU2 199606SU5 199789SU9 200679SU9 200680SU7 200960SU3 200961SU1 201077SU5 201214SU4 201610SU3 201613SU7 201618SU6 201969SU3 202467SU7 202468SU5 168065SU1 168066SU9 183103SU1 182236SU0 167276SU5 170347SU9 191696SU4 193657SU4 194546SU8 199357SU5 200678SU1 200708SU6 203046SU8 160385SU1 184516SU3 187647SU3 161693SU7 187020SU3 176017SU2 187019SU5 165582SU8 168319SU2 197942SU6 186622SU7 184408SU3 190751SU8 180773SU4 180774SU2 189164SU7 180771SU8 180772SU6 170666SU2 170668SU8 170667SU0 179252SU2 171948SU3 179458SU5 181425SU0 182229SU5 170677SU9 183919SU0 191472SU0 189171SU2 182374SU9 197245SU4 197246SU2 191540SU4 178030SU3 158761SU7 176141SU0 169512SU1 162600SU1 198439SU2 166184SU2 194539SU3 187592SU1 195874SU3 196265SU3 195866SU9 200705SU2 193474SU4 159243SU5 176126SU1 182225SU3 194185SU5 194191SU3 195857SU8 191541SU2 171938SU4 190392SU1 166173SU5 158765SU8 183111SU4 190409SU3 195867SU7 159250SU0 176124SU6 188123SU4 170680SU3 176016SU4 176014SU9 167275SU7 170271SU1 170198SU6 200707SU8 189675SU2 158259SU2 159240SU1 193357SU1 159245SU0 176134SU5 193449SU6 193450SU4 198893SU0 169507SU1 193949SU5 203456SU9 167648SU5 168521SU3 179023SU7 179324SU9 179325SU6 179326SU4 191243SU5 188357SU8 193343SU1 193637SU6 176887SU8 195232SU4 203337SU1 158246SU9 160531SU0 203458SU5 179997SU2 191892SU9 203450SU2 192109SU7 171032SU6 186601SU1 179998SU0 185067SU6 193038SU7 186726SU6 203125SU0 203338SU9 169486SU8 183101SU5 185315SU9 160530SU2 185799SU4 185800SU0 171033SU4 168778SU9 187782SU8 171255SU3 195229SU0 195230SU8 195231SU6 186727SU4 192108SU9 193338SU1 193339SU9 193340SU7 193341SU5 202469SU3 203459SU3 170682SU9 171939SU2 169491SU8 180764SU3 169492SU6 198420SU2 181430SU0 169490SU0 185298SU7 158801SU1 165597SU6 196267SU9 162592SU0 163227SU2 170678SU7 169489SU2 178024SU6 198909SU4 191559SU4 196260SU4 196261SU2 158762SU5 194532SU8 187584SU8 166182SU6 183117SU1 201234SU2 168067SU7 189170SU4 169488SU4 165581SU0 193957SU8 163226SU4 168054SU5 158803SU7 195862SU8 195861SU0 198876SU5 198877SU3 186623SU5 179272SU0 193947SU9 198875SU7 200164SU2 200165SU9 191065SU2 191064SU5 172241SU2 184017SU2 184517SU1 189940SU0 192544SU5 192545SU2 172240SU4 168854SU8 168855SU5 168079SU2 168077SU6 168078SU4 190373SU1 190383SU0 187590SU5 165596SU8 180767SU6 182375SU6 163228SU0 190414SU3 170892SU4 171940SU0 159252SU6 193950SU3 166186SU7 194192SU1 194533SU6 193448SU8 194193SU9 183923SU2 198883SU1 191568SU5 187009SU6 169498SU3 169499SU1 191462SU1 198912SU8 198913SU6 176008SU1 176009SU9 176010SU7 176011SU5 176012SU3 188122SU6 176140SU2 169500SU6 176142SU8 176143SU6 169494SU2 169495SU9 168061SU0 168062SU8 158804SU5 159791SU3 182383SU0 186589SU8 189174SU6 181427SU6 159790SU5 176137SU8 176145SU1 176146SU9 178014SU7 190377SU2 198884SU9 198892SU2 198917SU7 198918SU5 187593SU9 176119SU6 176120SU4 188125SU9 178015SU4 189177SU9 190374SU9 198886SU4 176118SU8 176144SU4 169496SU7 169497SU5 175619SU6 175620SU4 175621SU2 181428SU4 181429SU2 190376SU4 198888SU0 181426SU8 191461SU3 190413SU5 190411SU9 190412SU7 200956SU1 193882SU8 179457SU7 160126SU9 189429SU4 193879SU4 200952SU0 191536SU2 191538SU8 200957SU9 202730SU8 186631SU8 182659SU3 182660SU1 171022SU7 171031SU8 169348SU0 185137SU7 185140SU1 184029SU7 189439SU3 196893SU2 189433SU6 193887SU7 159771SU5 159133SU8 159256SU7 159135SU3 158236SU0 185127SU8 184041SU2 159773SU1 158237SU8 184032SU1 185134SU4 181235SU3 193135SU1 196877SU5 198900SU3 185135SU1 189936SU8 197659SU6 188974SU0 181642SU0 185138SU5 193497SU5 193500SU6 188973SU2 159772SU3 198414SU5 200955SU3 181643SU8 169788SU7 184025SU5 184027SU1 184028SU9 197178SU7 202727SU4 193136SU9 165329SU4 184022SU2 197660SU4 184021SU4 178009SU7 203039SU3 165576SU0 165579SU4 181644SU6 182437SU4 193884SU4 169784SU6 158239SU4 164379SU0 164381SU6 193137SU7 190421SU8 182440SU8 180109SU1 193138SU5 193141SU9 197174SU6 191534SU7 192309SU3 184039SU6 176004SU0 169346SU4 193134SU4 173822SU8 173823SU6 193892SU7 193898SU4 169785SU3 171030SU0 178951SU0 195243SU1 188972SU4 184030SU5 186634SU2 164265SU1 164380SU8 159134SU6 203901SU4 190423SU4 203906SU3 169780SU4 181645SU3 186624SU3 190416SU8 190417SU6 185126SU0 176005SU7 179455SU1 200959SU5 160528SU6 197180SU3 198905SU2 179452SU8 185133SU6 193498SU3 193501SU4 192313SU5 181641SU2 177276SU3 169781SU2 189931SU9 159254SU2 193883SU6 165746SU9 184020SU6 189432SU8 193132SU8 196888SU2 176007SU3 164377SU4 185125SU2 192312SU7 193139SU3 193140SU1 200954SU6 198412SU9 186629SU2 169782SU0 203041SU9 169343SU1 186626SU8 192310SU1 165325SU2 165326SU0 165327SU8 165332SU8 180107SU5 198410SU3 189932SU7 189938SU4 198417SU8 195252SU2 198413SU7 184019SU8 184036SU2 185123SU7 193899SU2 197181SU1 191535SU4 197179SU5 196892SU4 197183SU7 188976SU5 158235SU2 158242SU8 160529SU4 189430SU2 185131SU0 189431SU0 203043SU5 186637SU5 159770SU7 185121SU1 196894SU0 164267SU7 185118SU7 186632SU6 184034SU7 189428SU6 193133SU6 182662SU7 193894SU3 165577SU8 171024SU3 189437SU7 189438SU5 186633SU4 185122SU9 159769SU9 173363SU3 169345SU6 169344SU9 186630SU0 169347SU2 171023SU5 198908SU6 202729SU0 203042SU7 159257SU5 173821SU0 203036SU9 169777SU0 169787SU9 182441SU6 194548SU4 193142SU7 177277SU1 196887SU4 197182SU9 164378SU2 177081SU7 175345SU8 175344SU1 197184SU5 178008SU9 171027SU6 197177SU9 196891SU6 200958SU7 195245SU6 195254SU8 171029SU2 172651SU2 182658SU5 177275SU5 203040SU1 158238SU6 189933SU5 186635SU9 190418SU4 184026SU3 184040SU4 177083SU3 198418SU6 195250SU6 172649SU6 184031SU3 198906SU0 182442SU4 197185SU2 164264SU4 165323SU7 165324SU5 164263SU6 164266SU9 186625SU0 185117SU9 186628SU4 185120SU3 203034SU4 196889SU0 197176SU1 186636SU7 189435SU1 189436SU9 193876SU0 193878SU6 193880SU2 193885SU1 191539SU6 182439SU0 159253SU4 160128SU5 184023SU0 169778SU8 169786SU1 171028SU4 182438SU2 184033SU9 192311SU9 195244SU9 175342SU5 203038SU5 182657SU7 196886SU6 185136SU9 189929SU3 185119SU5 172648SU8 172650SU4 178007SU1 165328SU6 165330SU2 198411SU1 198902SU9 185128SU6 185132SU8 189934SU3 193881SU0 171025SU0 202726SU6 190420SU0 179456SU9 194553SU4 197944SU2 171021SU9 203035SU1 193891SU9 176006SU5 165578SU6 177082SU5 179454SU4 200953SU8 169783SU8 172652SU0 184038SU8 186627SU6 191537SU0 180105SU9 175343SU3 184035SU4 184037SU0 190422SU6 189935SU0 190415SU0 160130SU1 198904SU5 196890SU8 196897SU3 194552SU6 172654SU6 189434SU4 193499SU1 198901SU1 173365SU8 189937SU6 188975SU7 179453SU6 193895SU0 168692SU2 165749SU3 166467SU1 165739SU4 165747SU7 165745SU1 165744SU4 166465SU5 166468SU9 165738SU6 168691SU4 165741SU0 165743SU6 165740SU2 165748SU5 165742SU8 166464SU8 172655SU3 198907SU8 185124SU5 190424SU2 181646SU1 173820SU2 196896SU5 184024SU8 177278SU9 184018SU0 160527SU8 178006SU3 195879SU2 158240SU2 158241SU0 159132SU0 160127SU7 160129SU3 165331SU0 165333SU6 169779SU6 171026SU8 193888SU5 193889SU3 193890SU1 193893SU5 193896SU8 193897SU6 194551SU8 199487SU0 159255SU9 165580SU2 189939SU2 190419SU2 202728SU2 197175SU3 158235SU2 158238SU6 158239SU4 195877SU6 196895SU7 198415SU2 198416SU0 198419SU4 180108SU3 180110SU9 180632SU2 181231SU2 181232SU0 181233SU8 181234SU6 185139SU3 188977SU3 189930SU1 193877SU8 193886SU9 194547SU6 194549SU2 194550SU0 195246SU4 195247SU2 195248SU0 195249SU8 195251SU4 195253SU0 195878SU4 195880SU0 198903SU7 199353SU4 199354SU2 199355SU9 199356SU7 201070SU0 201071SU8 202722SU5 202723SU3 203037SU7 201619SU4 185130SU2 187583SU0 193143SU5 153251SU4 153252SU2 153253SU0 158799SU7 158808SU6 159780SU6 159787SU1 162601SU9 163222SU3 170670SU4 170893SU2 171937SU6 171941SU8 171943SU4 172243SU8 172653SU8 173362SU5 173364SU1 176123SU8 176125SU3 176129SU5 176260SU8 177080SU9 180108SU3 180766SU8 181432SU6 182226SU1 182661SU9 183909SU1 185129SU4 185293SU8 185296SU1 185617SU8 185618SU6 186591SU4 187007SU0 187016SU1 187017SU9 187582SU2 187586SU3 187587SU1 187589SU7 188118SU4 188126SU7 188126SU7 188129SU1 188130SU9 189178SU7 189179SU5 189181SU1 189182SU9 189184SU5 189690SU1 189694SU3 189695SU0 189696SU8 189923SU6 190375SU6 190378SU0 190379SU8 190386SU3 190389SU7 190394SU7 190397SU0 190398SU8 190402SU8 190408SU5 191011SU6 191012SU4 191066SU0 191067SU8 191464SU7 191467SU0 191468SU8 191469SU6 191470SU4 191533SU9 191542SU0 191548SU7 191551SU1 191552SU9 191553SU7 191555SU2 191556SU0 191557SU8 191565SU1 191566SU9 191569SU3 191680SU8 191681SU6 192554SU4 192555SU1 192556SU9 192557SU7 192558SU5 192559SU3 192560SU1 192561SU9 192562SU7 192563SU5 192564SU3 192565SU0 192566SU8 192567SU6 192708SU6 192709SU4 192929SU8 192953SU8 193447SU0 193901SU6 193928SU9 193948SU7 193951SU1 193953SU7 193955SU2 193956SU0 193958SU6 193959SU4 193961SU0 193962SU8 194180SU6 194183SU0 194184SU8 194188SU9 194189SU7 194195SU4 194196SU2 194197SU0 194523SU7 194524SU5 194525SU2 194529SU4 194530SU2 194531SU0 194536SU9 194541SU9 194543SU5 195859SU4 195860SU2 195868SU5 195869SU3 195870SU1 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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent on 2/8/2013 a GE Healthcare " Urgent Medical Device Correction" letter dated February 8, 2013. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering and Managers of General/Diagnostic Imaging. The letter described the Safety Issue, Safety Instructions, Affected Product details, Product correction and Contact Information. US customer contact number is (1)800-437-1171.
Quantity in Commerce 2061
Distribution Worldwide Distribution, USA, including the states of AL, AZ, AR, CA, CO,K CT, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT NE, NV N NJ, NM, NY, NC, ND, OH, OK, PA, RI ,SC, SD, TN, TX, VA, WA, WI and the countries of AUSTRALIA, AUSTRIA, BRAZIL, CANDA, CHILE, CHINA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY INDIA, INDONESIA ITALY JAPAN, KOREA, LATVIA, LEBANON, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA , SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = GE HEALTHCARE
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