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U.S. Department of Health and Human Services

Class 2 Device Recall GE LOGIQ P6 Ultrasound System

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 Class 2 Recall
GE LOGIQ P6 Ultrasound System
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Date Posted January 21, 2012
Recall Status1 Terminated on January 21, 2014
Recall Number Z-0834-2012
Recall Event ID 60781
Premarket Notification
510(K) Number
K073297 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and intraoperative (abdominal, thoracic, vascular and neurological).
Code Information Serial Number 144435SU5 133455SU6 140253SU6 140402SU9 143461SU2 135592SU4 135919SU9 143853SU0 143854SU8 143855SU5 143856SU3 143857SU1 143858SU9 144424SU9 136031SU2 137467SU7 138561SU6 140683SU4 144432SU2 144436SU3 144444SU7 144425SU6 144427SU2 144428SU0 144429SU8 144921SU4 146150SU8 146151SU6 146152SU4 146153SU2 146155SU7 146156SU5 146157SU3 146158SU1 146159SU9 146160SU7 146161SU5 146165SU6 146166SU4 146167SU2 146168SU0 146169SU8 146171SU4 146174SU8 148045SU8 148046SU6 148047SU4 148048SU2 148049SU0 148233SU0 148234SU8 148235SU5 148238SU9 148964SU0 148965SU7 148966SU5 148967SU3 149150SU5 149152SU1 149153SU9 149720SU5 149721SU3 149722SU1 149723SU9 150499SU2 150500SU7 150501SU5 151265SU6 151270SU6 151271SU4 151272SU2 151273SU0 151274SU8 151275SU5 151276SU3 151972SU7 151973SU5 151974SU3 151975SU0 151976SU8 151977SU6 151978SU4 151979SU2 151980SU0 152623SU5 152624SU3 152625SU0 152626SU8 153218SU3 153219SU1 153220SU9 153221SU7 153222SU5 153223SU3 153224SU1 153483SU3 153484SU1 153485SU8 154653SU0 154654SU8 155237SU1 155238SU9 155435SU1 155436SU9 155437SU7 155438SU5 155439SU3 155440SU1 156617SU3 156618SU1 156619SU9 156620SU7 156621SU5 156622SU3 157863SU2 157864SU0 157865SU7 157866SU5 157867SU3 157868SU1 157869SU9 157870SU7 161523SU6 161524SU4 162223SU2 162226SU5 133453SU1 136030SU4 136034SU6 136459SU5 138560SU8 141363SU2 143459SU6 144437SU1 144440SU5 144446SU2 144453SU8 133456SU4 133457SU2 133849SU0 137466SU9 138562SU4 140252SU8 134660SU0 140680SU0 140684SU2 136853SU9 141366SU5 144431SU4 135918SU1 141365SU7 144439SU7 144454SU6 135914SU0 143462SU0 138994SU9 136036SU1 137462SU8 140251SU0 144434SU8 136849SU7 133450SU7 133451SU5 140681SU8 140682SU6 144438SU9 144447SU0 144445SU4 133449SU9 135593SU2 135920SU7 140401SU1 134662SU6 143458SU8 141364SU0 141367SU3 144433SU0 139852SU8 138993SU1 135916SU6 139850SU2 133448SU1 144448SU8 136032SU0 133850SU8 144442SU1 144443SU9 144450SU4 144452SU0 133452SU3 133454SU9 134661SU8 136033SU8 136035SU3 136460SU3 136852SU1 136854SU7 137465SU1 138995SU6 139851SU0 143457SU0 143460SU4 143463SU8 143464SU6 135591SU6 135917SU3 133851SU6 135915SU8 136851SU3 137463SU6 137464SU4 144455SU3 135452SU1 135453SU9 135454SU7 147467SU5 147468SU3 147469SU1 133629SU6 133641SU1 149984SU7 145596SU3 148723SU0 148728SU9 148729SU7 148777SU6 149981SU3 151517SU0 154817SU1 136512SU1 136654SU1 137197SU0 145601SU1 147197SU8 149701SU5 149702SU3 149705SU6 135906SU6 143023SU0 148060SU7 148232SU2 148520SU0 140577SU8 140578SU6 144764SU8 134268SU2 141311SU1 146610SU1 149536SU5 155189SU4 158295SU6 159676SU6 160437SU0 156793SU2 157450SU8 161531SU9 149243SU8 149244SU6 149245SU3 149246SU1 149250SU3 149256SU0 149992SU0 150212SU9 150215SU2 150218SU6 150219SU4 154829SU6 154830SU4 154831SU2 154832SU0 155243SU9 155244SU7 155661SU2 155662SU0 135894SU4 135908SU2 135909SU0 135910SU8 135912SU4 136966SU9 137537SU7 137975SU9 137977SU5 137981SU7 137992SU4 138660SU6 142277SU3 142613SU9 142617SU0 142620SU4 143028SU9 143596SU5 143815SU9 147210SU9 148228SU0 148526SU7 148529SU1 133075SU2 149248SU7 149249SU5 149268SU5 153791SU9 155240SU5 155249SU6 155250SU4 155670SU3 155895SU6 135656SU7 135903SU3 136641SU8 138661SU4 139785SU0 142140SU3 143030SU5 143811SU8 143813SU4 144358SU9 145593SU0 146094SU8 148065SU6 148525SU9 148715SU6 134459SU7 142136SU1 146220SU9 147200SU0 148071SU4 133646SU0 139777SU7 136018SU9 136019SU7 149694SU2 137531SU0 137552SU6 147474SU1 147476SU6 147477SU4 133087SU7 148719SU8 148720SU6 149703SU1 149704SU9 154837SU9 136497SU5 136517SU0 136518SU8 136519SU6 136521SU2 136961SU0 136963SU6 137514SU6 137518SU7 137520SU3 137521SU1 137525SU2 137527SU8 138662SU2 139316SU4 140239SU5 142608SU9 143821SU7 148515SU0 148516SU8 139308SU1 139325SU5 137516SU1 136637SU6 136638SU4 136639SU2 139185SU3 139186SU1 139187SU9 139188SU7 139189SU5 139190SU3 139191SU1 139192SU9 139193SU7 139194SU5 139195SU2 139196SU0 139197SU8 139198SU6 139199SU4 140572SU9 140573SU7 140574SU5 140575SU2 140576SU0 140655SU2 140656SU0 140657SU8 140658SU6 140659SU4 140660SU2 140661SU0 140662SU8 140663SU6 140664SU4 141636SU1 141637SU9 141638SU7 141639SU5 141640SU3 141641SU1 141642SU9 141643SU7 142662SU6 142910SU9 142911SU7 142912SU5 142913SU3 142914SU1 144922SU2 144923SU0 145224SU2 145225SU9 145226SU7 145227SU5 145228SU3 145229SU1 145230SU9 145231SU7 145232SU5 145233SU3 145234SU1 145235SU8 145236SU6 145237SU4 145238SU2 146423SU9 146424SU7 146425SU4 146426SU2 146427SU0 146428SU8 146429SU6 147490SU7 147491SU5 148950SU9 148951SU7 148952SU5 148953SU3 148954SU1 148955SU8 148956SU6 148957SU4 148958SU2 148959SU0 148960SU8 148961SU6 148962SU4 148963SU2 151279SU7 151280SU5 151281SU3 151282SU1 151283SU9 152617SU7 152946SU0 152947SU8 152948SU6 155323SU9 155324SU7 155325SU4 155326SU2 155327SU0 156800SU5 156801SU3 156802SU1 156803SU9 156804SU7 156805SU4 159236SU9 159237SU7 159239SU3 159818SU4 159819SU2 159820SU0 143595SU7 143806SU8 137143SU4 137144SU2 143851SU4 143852SU2 144469SU4 145059SU2 135654SU2 138687SU9 140230SU4 142274SU0 142917SU4 143589SU0 147023SU6 147029SU3 147034SU3 147035SU0 147195SU2 147483SU2 149261SU0 149270SU1 149980SU5 159090SU0 159091SU8 133639SU5 133642SU9 153790SU1 155668SU7 135898SU5 136515SU4 136516SU2 136520SU4 136652SU5 137189SU7 137547SU6 137549SU2 138690SU3 139779SU3 142144SU5 142604SU8 142929SU9 143809SU2 144361SU3 146221SU7 147187SU9 148059SU9 148510SU1 133790SU6 146544SU2 149201SU6 132634SU7 156650SU4 133637SU9 133638SU7 155252SU0 134442SU3 139305SU7 139771SU0 153498SU1 157113SU2 157114SU0 140308SU8 140678SU4 132820SU2 139853SU6 140307SU0 136956SU0 142924SU0 145594SU8 155868SU3 139767SU8 145602SU9 147201SU8 136957SU8 133643SU7 133644SU5 148061SU5 133237SU8 133238SU6 133241SU0 133242SU8 133243SU6 133245SU1 133247SU7 133248SU5 133982SU9 133983SU7 133985SU2 133986SU0 133987SU8 133988SU6 133989SU4 133990SU2 133992SU8 133993SU6 134722SU8 134723SU6 134724SU4 134725SU1 134726SU9 134896SU0 134624SU6 134625SU3 134626SU1 134627SU9 134628SU7 135622SU9 135623SU7 135624SU5 135625SU2 135626SU0 135627SU8 135628SU6 135629SU4 135630SU2 135631SU0 136020SU5 136021SU3 136022SU1 136023SU9 136024SU7 136025SU4 136026SU2 136027SU0 136028SU8 136029SU6 136461SU1 136462SU9 136463SU7 136464SU5 136465SU2 136466SU0 136467SU8 136468SU6 136469SU4 136470SU2 136941SU2 136942SU0 136943SU8 136944SU6 136945SU3 136946SU1 136947SU9 136948SU7 137257SU2 137258SU0 137259SU8 137260SU6 137261SU4 137262SU2 137263SU0 138444SU5 138445SU2 138446SU0 138447SU8 138448SU6 138799SU2 138800SU8 138801SU6 138802SU4 138803SU2 139876SU7 139877SU5 142148SU6 142149SU4 142150SU2 142151SU0 142152SU8 142153SU6 142154SU4 142155SU1 142156SU9 142157SU7 142158SU5 142159SU3 142160SU1 142529SU7 142530SU5 142531SU3 142532SU1 142533SU9 142534SU7 142535SU4 142536SU2 143014SU9 143015SU6 143016SU4 143017SU2 143018SU0 143019SU8 143020SU6 143021SU4 143156SU8 143157SU6 143158SU4 143159SU2 143160SU0 143161SU8 143162SU6 143163SU4 143411SU7 143412SU5 143413SU3 143414SU1 144073SU4 144074SU2 144075SU9 144076SU7 144077SU5 144078SU3 144079SU1 144080SU9 145045SU1 145046SU9 145047SU7 145048SU5 145049SU3 145307SU5 145308SU3 145821SU5 145822SU3 145823SU1 145824SU9 145825SU6 146418SU9 146419SU7 146420SU5 146421SU3 146422SU1 146875SU0 146876SU8 146877SU6 146878SU4 146879SU2 146880SU0 146881SU8 146882SU6 146883SU4 146884SU2 146885SU9 146886SU7 146887SU5 146888SU3 146889SU1 147212SU5 147213SU3 147214SU1 147215SU8 147216SU6 147217SU4 147218SU2 148050SU8 148051SU6 148052SU4 148053SU2 148054SU0 148055SU7 148056SU5 148057SU3 148337SU9 148338SU7 148339SU5 148340SU3 148341SU1 148342SU9 148343SU7 148344SU5 148706SU5 148707SU3 148708SU1 148709SU9 148710SU7 149155SU4 149156SU2 149157SU0 149158SU8 149159SU6 149202SU4 149203SU2 149204SU0 149205SU7 149206SU5 150323SU4 150324SU2 150325SU9 150326SU7 150327SU5 150932SU2 150933SU0 150934SU8 150935SU5 151806SU7 151807SU5 151808SU3 151809SU1 152628SU4 152629SU2 152630SU0 152631SU8 153486SU6 153487SU4 153488SU2 153489SU0 153490SU8 153491SU6 153492SU4 153493SU2 153494SU0 153495SU7 153496SU5 154656SU3 154657SU1 154658SU9 154659SU7 154660SU5 154661SU3 154662SU1 154663SU9 154839SU5 155097SU9 155098SU7 155099SU5 155100SU1 155101SU9 155102SU7 155103SU5 155104SU3 155580SU4 155581SU2 155582SU0 155583SU8 155584SU6 155585SU3 155586SU1 155587SU9 156107SU5 156108SU3 156109SU1 156110SU9 156111SU7 156112SU5 156113SU3 156806SU2 156807SU0 156808SU8 156809SU6 156810SU4 157405SU1 157406SU9 157407SU7 157408SU5 157409SU3 158009SU1 158010SU9 158011SU7 158012SU5 158013SU3 158014SU1 158015SU8 158016SU6 159272SU4 159273SU2 159274SU0 159275SU7 159276SU5 159277SU3 159278SU1 159279SU9 159280SU7 159281SU5 160025SU3 160027SU9 160028SU7 160029SU5 160032SU9 160033SU7 161504SU6 161505SU3 161506SU1 161507SU9 161508SU7 161509SU5 161510SU3 158279SU0 160738SU1 149264SU4 149265SU1 149266SU9 149688SU4 149691SU8 149695SU9 149989SU6 153866SU9 153868SU5 154846SU0 155263SU7 155673SU7 155883SU2 155884SU0 155894SU9 156640SU5 156643SU9 156644SU7 156645SU4 156646SU2 156795SU7 136647SU5 137186SU3 137192SU1 137544SU3 137990SU8 138002SU1 138004SU7 138006SU2 138007SU0 138681SU2 138682SU0 142281SU5 142607SU1 142622SU0 142623SU8 142624SU6 142625SU3 143027SU1 143597SU3 143598SU1 144366SU2 144367SU0 144373SU8 144896SU8 144897SU6 144899SU2 144900SU8 145590SU6 145592SU2 145595SU5 145603SU7 145604SU5 145605SU2 146095SU5 147188SU7 147196SU0 147198SU6 147202SU6 147203SU4 147205SU9 147471SU7 148716SU4 136636SU8 136821SU6 136822SU4 139208SU3 139872SU6 139873SU4 139874SU2 139875SU9 140653SU7 140654SU5 146890SU9 133381SU4 133668SU4 133791SU4 134685SU7 135097SU4 138559SU0 140491SU2 142261SU7 143378SU8 143410SU9 143859SU7 144111SU2 142660SU0 142661SU8 144110SU4 145303SU4 145304SU2 145305SU9 145390SU1 145769SU6 146458SU5 147012SU9 147827SU0 147830SU4 148129SU0 148130SU8 148705SU7 150211SU1 150804SU3 151259SU9 151260SU7 151261SU5 151489SU2 151490SU0 154650SU6 158278SU2 159085SU0 159087SU6 159635SU2 159997SU6 158367SU3 135897SU7 143200SU4 143820SU9 143973SU6 150802SU7 155186SU0 155188SU6 133779SU9 135412SU5 136820SU8 133072SU9 133074SU5 133636SU1 133640SU3 155876SU6 155879SU0 155880SU8 155881SU6 155886SU5 156623SU1 156629SU8 156641SU3 156642SU1 156647SU0 156648SU8 156649SU6 156651SU2 156790SU8 156791SU6 156792SU4 156794SU0 157446SU6 157449SU0 158371SU5 159089SU2 161526SU9 161528SU5 148725SU5 148726SU3 148727SU1 149247SU9 149251SU1 149252SU9 149253SU7 149255SU2 149263SU6 149271SU9 149272SU7 149689SU2 149690SU0 149692SU6 149693SU4 149699SU1 149985SU4 149986SU2 149987SU0 149988SU8 149993SU8 149994SU6 150214SU5 150216SU0 150220SU2 150221SU0 150862SU1 150863SU9 150864SU7 150865SU4 150866SU2 150867SU0 150868SU8 150869SU6 150870SU4 150871SU2 151494SU2 151495SU9 151497SU5 151498SU3 151499SU1 151500SU6 151502SU2 151507SU1 151508SU9 151510SU5 151511SU3 151512SU1 151513SU9 151514SU7 151515SU4 151516SU2 153385SU0 153386SU8 153780SU2 153782SU8 153784SU4 153786SU9 153788SU5 153795SU0 153796SU8 153867SU7 153869SU3 153870SU1 153871SU9 153872SU7 153875SU0 153876SU8 154818SU9 154819SU7 154820SU5 154828SU8 154833SU8 154842SU9 155241SU3 155242SU1 155246SU2 155247SU0 155253SU8 155256SU1 155257SU9 155258SU7 155259SU5 155265SU2 155647SU1 155648SU9 155649SU7 155651SU3 155653SU9 155663SU8 155664SU6 155665SU3 155666SU1 155667SU9 155669SU5 155671SU1 155672SU9 155674SU5 155675SU2 134440SU7 134441SU5 134444SU9 134448SU0 134449SU8 134450SU6 134451SU4 134455SU5 134457SU1 134458SU9 135648SU4 135649SU2 135650SU0 135658SU3 135659SU1 135660SU9 135899SU3 135900SU9 135904SU1 135905SU8 135907SU4 135911SU6 135913SU2 135970SU2 135972SU8 136498SU3 136499SU1 136500SU6 136501SU4 136502SU2 136505SU5 136506SU3 136507SU1 136508SU9 136509SU7 136510SU5 136511SU3 136646SU7 136651SU7 136949SU5 136951SU1 136952SU9 136958SU6 136962SU8 136967SU7 136968SU5 136969SU3 136971SU9 136972SU7 137188SU9 137190SU5 137191SU3 137193SU9 137194SU7 137195SU4 137196SU2 137198SU8 137199SU6 137515SU3 137519SU5 137523SU7 137524SU5 137528SU6 137529SU4 137530SU2 137532SU8 137533SU6 137534SU4 137535SU1 137536SU9 137538SU5 137539SU3 137542SU7 137543SU5 137545SU0 137546SU8 137548SU4 137550SU0 137551SU8 137553SU4 137974SU2 137976SU7 137979SU1 137980SU9 137984SU1 137986SU6 137995SU7 137996SU5 137997SU3 137998SU1 138657SU2 138658SU0 138659SU8 138663SU0 138664SU8 138665SU5 138666SU3 138667SU1 138668SU9 138669SU7 138670SU5 138672SU1 138674SU7 138675SU4 138676SU2 138677SU0 138678SU8 138679SU6 138680SU4 138683SU8 138684SU6 138685SU3 138686SU1 138689SU5 139274SU5 139276SU0 139277SU8 139307SU3 139309SU9 139311SU5 139312SU3 139313SU1 139314SU9 139315SU6 139322SU2 139323SU0 139324SU8 139327SU1 139328SU9 139329SU7 139763SU7 139764SU5 139765SU2 139768SU6 139769SU4 139772SU8 139782SU7 139783SU5 139784SU3 140227SU0 140231SU2 140232SU0 140233SU8 140234SU6 140235SU3 140236SU1 140237SU9 140238SU7 140240SU3 140953SU1 140954SU9 140955SU6 140956SU4 140957SU2 140958SU0 140959SU8 140960SU6 140962SU2 141952SU2 141953SU0 141954SU8 141955SU5 141956SU3 141957SU1 141958SU9 141959SU7 141960SU5 141961SU3 141962SU1 141966SU2 142129SU6 142131SU2 142134SU6 142137SU9 142141SU1 142142SU9 142143SU7 142145SU2 142146SU0 142147SU8 142272SU4 142273SU2 142275SU7 142276SU5 142601SU4 142602SU2 142603SU0 142610SU5 142612SU1 142614SU7 142616SU2 142618SU8 142619SU6 142621SU2 142920SU8 142921SU6 142922SU4 142923SU2 142925SU7 143022SU2 143024SU8 143025SU5 143026SU3 143029SU7 143031SU3 143196SU4 143197SU2 143594SU0 143599SU9 143600SU5 143601SU3 143602SU1 143603SU9 143605SU4 143810SU0 143814SU2 143816SU7 143817SU5 143818SU3 143823SU3 143824SU1 143829SU0 144359SU7 144360SU5 144362SU1 144363SU9 144368SU8 144370SU4 144375SU3 144376SU1 144377SU9 144898SU4 144901SU6 144902SU4 144903SU2 144904SU0 145452SU9 145454SU5 145455SU2 145456SU0 145584SU9 145585SU6 145586SU4 145587SU2 145588SU0 145589SU8 145591SU4 145597SU1 145598SU9 145599SU7 146097SU1 146215SU9 146217SU5 146218SU3 146219SU1 147016SU0 147017SU8 147024SU4 147030SU1 147031SU9 147033SU5 147189SU5 147191SU1 147192SU9 147193SU7 147194SU5 147199SU4 147204SU2 147206SU7 147207SU5 147470SU9 147480SU8 147481SU6 147482SU4 147488SU1 147489SU9 148058SU1 148068SU0 148070SU6 148077SU1 148230SU6 148511SU9 148512SU7 148513SU5 148514SU3 148518SU4 148519SU2 148521SU8 148522SU6 148523SU4 148527SU5 148711SU5 148712SU3 148718SU0 158355SU8 133086SU9 149258SU6 149698SU3 153778SU6 153779SU4 153873SU5 154840SU3 154841SU1 155864SU2 155865SU9 155872SU5 134443SU1 135657SU5 135971SU0 136513SU9 136514SU7 136950SU3 136953SU7 137541SU9 137994SU0 138688SU7 139773SU6 139774SU4 139778SU5 140226SU2 141963SU9 141964SU7 142926SU5 143586SU6 143587SU4 143807SU6 143808SU4 143825SU8 143827SU4 145451SU1 146093SU0 147019SU4 147025SU1 147026SU9 147027SU7 147472SU5 147478SU2 147484SU0 147485SU7 147486SU5 147487SU3 148073SU0 148074SU8 148075SU5 148724SU8 149254SU5 151503SU0 153793SU5 154834SU6 155871SU7 135661SU7 136644SU2 138003SU9 139318SU0 139319SU8 142918SU2 143592SU4 145600SU3 154814SU8 149697SU5 153797SU6 142606SU3 153389SU2 153794SU3 134453SU0 139320SU6 139321SU4 135895SU1 138001SU3 140961SU4 148063SU1 144762SU2 156011SU9 136504SU8 137983SU3 137988SU2 139275SU2 139317SU2 133446SU5 133447SU3 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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 recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. Contact the GE Support Center at 1-800-321-7937 or your local GE Healthcare service representative for questions regarding this issue.
Quantity in Commerce 2270
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KY, LA, ME, MA, MI, MN, MS, MO, MT, NE, NV, NH, NY, NC, ND, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, and WI. and countries of VENEZUELA, UNITED KINGDOM TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARAIA, RUSSIAN FEDERATION, ROMANIA, REPUBLIC OF KOREA, QATAR, PROTUGAL, POLAND, PHILIPPINES, PERU, OMAN, NORWAY, MEXICO, MALAYSIA, LITHUANIA, LEBANON, KOSOVO, KENYA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ONDONESIA, INDIA, HUNGRY, HONG KONG, GUATEMALA, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, and ALGERIA.
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 = GENERAL ELECTRIC CO.
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