GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions…

Date

April 17, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

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.

Reason

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

Distribution pattern

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.

Quantity

2061

Codes and lots

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…

Recall started

Feb. 8, 2013

Device type

System, Imaging, Pulsed Doppler, Ultrasonic

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-1096-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1096-2013. The agency record governs; check it and the company before acting.