GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage…

Date

Feb. 6, 2019

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 P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation 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); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

Reason

Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.

Distribution pattern

Worldwide distribution.

Quantity

1,897 units

Codes and lots

Serial Numbers: (a) Model BT09 130913SU7 127352SU3 130833SU7 130916SU0 125037SU2 116717SU0 130918SU6 131929SU2 127354SU9 126738SU4 106959SU0 114157SU1 115431SU9 115621SU5 106958SU2 116720SU4 121210SU9 130914SU5 130919SU4 132216SU3 113312SU3 130241SU3 111546SU8 120810SU7 112875SU0 123137SU2 112879SU2 112095SU5 113765SU2 115170SU3 117847SU4 128516SU2 103781SU1 131404SU6 125738SU5 120806SU5 120808SU1 127924SU9 128512SU1 128830SU7 128827SU3 130243SU9 106949SU1 122763SU6 111035SU2 111034SU5 112405SU6 106953SU3 110077SU5 113766SU0 106951SU7 116713SU9 122758SU6 127351SU5 130242SU1 111549SU2 126600SU6 126739SU2 112799SU2 123139SU8 121513SU6 123136SU4 128513SU9 131407SU9 123138SU0 122115SU9 118304SU5 132214SU8 132371SU6 106962SU4 123141SU4 113310SU7 115626SU4 113313SU1 121212SU5 126126SU2 111548SU4 132372SU4 121209SU1 130917SU8 128826SU5 122426SU0 127923SU1 113767SU8 106952SU5 112876SU8 131926SU8 126542SU0 128828SU1 120807SU3 114158SU9 112878SU4 131930SU0 132217SU1 130837SU8 114636SU4 130915SU2 132370SU8 125741SU9 127347SU3 122117SU5 126740SU0 122422SU9 118303SU7 115432SU7 115433SU5 132218SU9 121211SU7 122756SU0 122761SU0 125033SU1 120809SU9 115623SU1 127348SU1 122430SU2 116715SU4 116714SU7 106957SU4 115624SU9 130836SU0 112880SU0 130835SU2 114159SU7 131408SU7 131405SU3 120803SU2 121511SU0 121509SU4 114637SU2 115622SU3 125739SU3 125736SU9 125740SU1 106960SU8 122118SU3 125038SU0 127925SU6 110529SU5 122424SU5 125036SU4 126543SU8 115171SU1 130834SU5 112877SU6 116719SU6 125035SU6 121510SU2 112094SU8 106945SU9 122759SU4 126128SU8 122423SU7 116711SU3 131098SU6 131097SU8 131095SU2 131094SU5 122970SU7 126955SU4 120371SU0 126321SU9 131875SU7 107577SU9 109713SU8 128321SU7 130282SU7 127191SU5 106008SU6 126319SU3 107573SU8 120307SU4 122000SU3 119052SU9 119051SU1 121753SU8 124984SU6 124997SU8 126953SU9 116922SU6 130294SU2 124979SU6 109840SU9 128917SU2 118015SU7 118016SU5 118017SU3 118005SU8 118006SU6 118008SU2 118007SU4 118000SU9 117999SU3 118010SU8 117996SU9 118028SU0 118027SU2 118030SU6 118029SU8 118001SU7 118002SU5 118014SU0 118021SU5 118023SU1 118022SU3 118024SU9 118043SU9 118041SU3 118040SU5 118039SU7 118038SU9 118035SU5 118036SU3 118037SU1 118033SU0 118032SU2 118034SU8 118018SU1 118020SU7 118019SU9 118025SU6 118026SU4 118004SU1 118003SU3 119042SU0 123762SU7 126088SU4 128668SU1 130240SU5 116811SU1 128657SU4 127345SU7 128662SU4 128664SU0 128658SU2 116813SU7 123758SU5 116816SU0 125161SU0 115439SU2 121507SU8 126822SU6 121508SU6 123755SU1 127344SU0 116176SU9 116180SU1 115442SU6 115443SU4 116817SU8 127475SU2 127476SU0 127473SU7 127474SU5 115440SU0 116814SU5 126087SU6 123757SU7 116819SU4 128666SU5 127922SU3 116812SU9 128656SU6 128661SU6 119923SU1 116179SU3 116820SU2 123760SU1 123759SU3 123753SU6 123752SU8 123750SU2 126598SU2 127466SU1 127468SU7 127470SU3 127469SU5 130200SU9 130201SU7 122755SU2 123749SU4 126086SU8 116818SU6 116815SU2 126085SU0 123751SU0 123761SU9 123763SU5 116173SU6 126596SU6 126597SU4 116177SU7 128665SU7 126595SU8 116175SU1 123756SU9 123754SU4 127471SU1 127472SU9 128667SU3 128663SU2 128660SU8 116178SU5 116174SU4 127346SU5 107597SU7 130807SU1 124552SU1 124554SU7 120383SU5 124556SU2 124553SU9 129687SU0 122959SU0 124555SU4 121440SU2 122958SU2 120382SU7 130821SU2 130822SU0 130820SU4 129046SU9 127465SU3 125248SU5 128911SU5 129328SU1 123324SU6 121441SU0 129043SU6 129737SU3 119623SU7 124130SU6 111945SU2 117622SU1 116875SU6 120888SU3 123373SU3 129042SU8 118426SU6 126347SU4 125356SU6 128825SU7 115172SU9 111378SU6 111377SU8 121506SU0 129326SU5 128553SU5 128655SU8 121763SU7 109832SU6 116326SU0 124978SU8 130824SU6 109831SU8 122209SU0 128915SU6 128912SU3 115104SU2 119050SU3 132582SU8 116918SU4 130762SU8 116328SU6 109843SU3 109709SU6 116923SU4 124516SU6 124517SU4 121744SU7 127193SU1 127192SU3 112101SU1 121047SU5 121748SU8 131723SU9 131727SU0 131725SU4 114370SU0 131728SU8 112104SU5 115824SU5 121746SU2 130764SU4 116920SU0 126960SU4 107581SU1 130763SU6 126964SU6 127190SU7 107582SU9 116924SU2 120308SU2 111380SU2 131729SU6 131083SU8 130284SU3 123421SU0 106426SU0 121998SU9 107585SU2 107572SU0 116935SU8 131892SU2 131891SU4 119045SU3 109845SU8 123420SU2 123127SU3 106432SU8 120376SU9 125361SU6 130291SU8 120312SU4 130292SU6 114368SU4 119043SU8 107594SU4 115108SU3 121743SU9 122986SU3 132579SU4 121990SU6 116921SU8 119044SU6 116355SU9 107575SU3 120374SU4 120372SU8 126316SU9 115821SU1 129352SU1 115841SU9 132574SU5 107595SU1 113651SU4 111379SU4 120811SU5 129354SU7 127890SU2 125554SU6 109828SU4 116346SU8 116348SU4 114355SU1 130757SU8 130756SU0 116342SU7 114821SU2 122207SU4 132594SU3 119772SU2 109839SU1 122211SU6 114373SU4 126952SU1 107574SU6 110488SU4 116933SU3 125564SU5 127892SU8 110496SU7 116340SU1 131876SU5 122212SU4 120309SU0 123419SU4 119053SU7 122965SU7 122215SU7 109725SU2 109565SU2 116926SU7 111381SU0 116352SU6 120388SU4 120378SU5 110884SU4 121749SU6 109846SU6 114811SU3 129355SU4 127197SU2 109720SU3 107599SU3 119765SU6 121991SU4 131873SU2 111082SU4 116919SU2 114818SU8 131872SU4 113647SU2 122966SU5 109819SU3 110497SU5 131717SU1 111097SU2 115844SU3 107591SU0 126956SU2 111383SU6 115118SU2 132576SU0 122971SU5 106427SU8 109727SU8 114371SU8 109721SU1 121044SU2 121760SU3 119768SU0 127888SU6 123372SU5 116353SU4 110499SU1 116320SU3 128303SU5 109822SU7 110881SU0 115115SU8 121745SU4 124986SU1 126323SU5 120814SU9 116349SU2 116344SU3 106430SU2 125549SU6 121045SU9 106434SU4 109718SU7 120815SU6 123128SU1 130285SU0 115116SU6 119056SU0 106502SU8 111084SU0 110883SU6 110504SU8 128584SU0 107598SU5 117685SU8 109564SU5 112103SU7 114153SU0 114365SU0 122984SU8 130828SU7 120385SU0 123423SU6 116341SU9 119767SU2 119770SU6 109714SU6 122001SU1 123371SU7 124991SU1 128306SU8 114819SU6 121999SU7 113650SU6 115822SU9 107601SU7 122967SU3 131086SU1 128914SU9 117688SU2 110500SU6 122964SU0 106007SU8 109726SU0 119773SU0 125561SU1 126961SU2 126322SU7 114810SU5 120310SU8 111081SU6 115847SU6 119771SU4 121043SU4 109559SU5 131089SU5 114366SU8 131870SU8 119055SU2 123424SU4 116319SU5 115843SU5 107600SU9 109829SU2 111382SU8 114364SU3 114820SU4 125562SU9 127887SU8 128585SU7 132578SU6 123426SU9 131088SU7 131888SU0 126957SU0 121989SU8 131085SU3 119054SU5 123422SU8 126314SU4 109719SU5 128586SU5 130283SU5 109838SU3 127872SU0 125560SU3 120370SU2 107576SU1 130832SU9 120311SU6 130281SU9 114354SU4 106505SU1 121759SU5 115105SU9 120389SU2 130765SU1 115849SU2 115850SU0 120377SU7 111083SU2 115109SU1 131719SU7 107579SU5 115846SU8 127885SU2 120379SU3 130827SU9 130831SU1 129353SU9 106433SU6 132577SU8 116356SU7 131096SU0 109830SU0 128320SU9 116347SU6 126954SU7 130825SU3 131718SU9 106503SU6 107586SU0 107590SU2 110498SU3 116932SU5 117687SU4 122969SU9 128578SU2 121747SU0 128305SU0 116931SU7 115845SU0 115823SU7 127889SU4 128302SU7 124983SU8 115117SU4 115848SU4 128913SU1 121988SU0 128576SU6 111098SU0 109563SU7 127198SU0 120306SU6 116351SU8 126958SU8 122983SU0 107592SU8 115101SU8 120390SU0 119766SU4 124985SU3 116339SU3 128593SU1 131874SU0 127886SU0 115119SU0 107596SU9 116350SU0 110880SU2 114807SU1 122216SU5 128318SU3 128575SU8 125563SU7 111080SU8 123370SU9 125558SU7 127891SU0 128322SU5 119769SU8 116327SU8 120393SU4 122968SU1 125565SU2 130760SU2 121752SU0 126965SU3 109562SU9 106504SU4 131871SU6 109560SU3 127871SU2 119764SU9 122213SU2 125559SU5 130829SU5 128591SU5 128319SU1 121987SU2 115825SU2 125566SU0 109820SU1 125567SU8 109818SU5 113652SU2 113653SU0 128574SU1 116323SU7 121997SU1 110491SU8 115100SU0 116917SU6 106428SU6 122960SU8 112272SU0 129755SU5 127250SU9 123980SU5 122131SU6 128654SU1 129700SU1 110183SU1 111550SU0 131403SU8 131493SU9 118801SU6 123323SU8 116986SU1 113046SU7 123981SU3 112273SU8 131907SU8 126575SU0 118261SU7 126346SU6 129756SU3 118260SU9 118344SU1 112499SU9 117683SU3 117681SU7 108969SU7 123529SU0 123966SU4 129585SU6 117678SU3 117680SU9 117682SU5 130187SU8 130191SU0 130188SU6 117679SU1 129744SU9 129745SU6 129743SU1 130189SU4 130192SU8 130190SU2 113649SU8 129350SU5 124981SU2 122985SU5 124990SU3 106501SU0 127884SU5 120813SU1 115829SU4 119048SU7 131877SU3 132570SU3 109716SU1 119049SU5 120314SU0 113648SU0 109715SU3 131100SU0 107588SU6 124993SU7 124995SU2 124989SU5 109708SU8 123417SU8 107593SU6 127199SU8 129351SU3 132580SU2 106425SU2 107587SU8 119047SU9 127883SU7 131099SU4 109717SU9 124992SU9 121544SU1 109551SU2 110084SU1 110090SU8 110447SU0 111386SU9 112003SU9 112275SU3 113043SU4 114803SU0 115096SU0 115095SU2 120305SU8 120304SU1 120893SU3 120894SU1 121218SU2 121222SU4 121851SU0 122315SU5 126578SU4 131062SU2 132221SU3 119270SU7 121842SU9 124775SU8 130743SU8 131061SU4 120301SU7 120300SU9 130745SU3 110086SU6 111387SU7 121849SU4 128254SU0 109555SU3 120296SU9 123917SU7 132223SU9 102385SU2 119268SU1 113535SU9 119267SU3 124776SU6 130744SU6 132222SU1 111312SU5 111385SU1 114805SU5 114806SU3 117623SU9 122306SU4 124766SU7 132224SU7 111311SU7 113044SU2 113042SU6 113192SU9 113531SU8 114804SU8 122311SU4 122312SU2 124772SU5 124769SU1 126579SU2 128256SU5 128517SU0 130097SU9 132220SU5 118263SU3 110446SU2 111309SU1 131070SU5 109554SU6 109556SU1 113823SU9 114802SU2 118265SU8 121443SU6 109548SU8 107934SU2 109549SU6 131068SU9 109553SU8 112001SU3 113541SU7 113529SU2 113528SU4 119271SU5 121445SU1 123913SU6 128519SU6 131067SU1 110085SU8 113193SU7 113826SU2 117628SU8 120889SU1 121844SU5 112274SU6 121444SU4 121850SU2 131065SU5 131063SU0 130096SU1 115098SU6 123914SU4 108309SU6 108310SU4 108311SU2 108312SU0 108313SU8 108308SU8 110088SU2 110083SU3 115099SU4 128255SU7 113543SU3 117625SU4 121843SU7 125249SU3 128253SU2 120892SU5 126577SU6 109545SU4 111999SU9 111310SU9 107937SU5 109557SU9 111389SU3 111388SU5 112276SU1 121219SU0 122314SU8 122313SU0 123912SU8 123918SU5 124762SU6 124773SU3 130094SU6 130093SU8 132219SU7 107933SU4 109550SU4 110091SU6 113045SU9 113536SU7 113532SU6 121848SU6 123916SU9 124774SU1 124767SU5 125252SU7 109546SU2 120891SU7 121446SU9 107936SU7 109547SU0 110089SU0 113538SU3 121220SU8 121221SU6 121846SU0 124764SU2 130742SU0 113539SU1 113530SU0 107935SU9 109552SU0 110092SU4 112000SU5 112002SU1 113542SU5 113540SU9 113824SU7 113825SU4 113822SU1 113828SU8 117626SU2 117627SU0 117624SU7 118266SU6 118264SU1 118268SU2 119269SU9 120303SU3 120302SU5 120298SU5 120295SU1 120890SU9 121442SU8 122310SU6 122308SU0 124771SU7 124770SU9 124763SU4 128252SU4 128518SU8 131064SU8 113827SU0 115097SU8 122307SU2 125250SU1 110445SU4 120294SU4 130095SU3 131715SU5 115827SU8 125357SU4 125552SU0 131081SU2 131889SU8 124988SU7 124987SU9 113654SU8 125550SU4 114357SU7 131090SU3 120386SU8 109566SU0 118982SU8 111384SU4 118425SU8 108156SU1 122987SU1 130826SU1 131868SU2 131869SU0 125555SU3 116934SU1 110492SU6 126315SU1 130759SU4 110490SU0 126318SU5 107580SU3 125551SU2 109711SU2 108771SU7 109724SU5 127196SU4 122972SU3 122119SU1 110502SU2 127195SU6 110495SU9 128588SU1 120315SU7 110882SU8 114369SU2 128324SU1 130761SU0 128587SU3 123425SU1 128325SU8 126320SU1 127868SU8 114367SU6 128589SU9 119046SU1 115103SU4 128326SU6 121761SU1 123131SU5 106508SU5 125548SU8 106507SU7 124982SU0 131084SU6 123130SU7 116928SU3 109841SU7 128323SU3 116929SU1 128577SU4 121741SU3 130295SU9 125359SU0 122962SU4 106506SU9 115102SU6 121740SU5 116357SU5 115830SU2 115828SU6 114358SU5 116936SU6 127873SU8 131716SU3 116358SU3 122961SU6 126963SU8 114808SU9 116354SU2 106429SU4 121739SU7 127866SU2 111708SU4 129903SU1 109085SU1 111713SU4 107209SU9 111551SU8 124962SU2 109087SU7 111707SU6 115820SU3 129900SU7 129899SU1 131663SU7 110078SU3 118258SU3 130244SU7 127867SU0 112717SU4 125908SU4 125907SU6 107212SU3 108942SU4 108943SU2 116874SU9 131664SU5 111711SU8 111710SU0 119622SU9 128976SU8 107210SU7 120381SU9 128977SU6 131667SU8 121214SU1 127865SU4 131665SU2 128980SU0 128978SU4 107206SU5 111712SU6 128979SU2 107213SU1 110184SU9 112927SU9 114845SU1 121215SU8 121213SU3 121217SU4 125733SU6 125734SU4 128975SU0 130168SU8 131666SU0 114885SU7 129901SU5 107208SU1 114851SU9 120380SU1 121216SU6 121404SU8 121403SU0 123558SU9 107205SU7 129902SU3 110079SU1 107583SU7 117684SU1 131087SU9 132583SU6 132592SU7 132588SU5 132586SU9 120313SU2 132587SU7 132585SU1 130758SU6 132584SU4 132593SU5 128590SU7 115842SU7 132589SU3 132591SU9 127875SU3 131726SU2 127874SU6 128304SU3…

Recall started

Dec. 28, 2018

Device type

System, Imaging, Pulsed Doppler, Ultrasonic

Root cause (FDA)

Device Design

What the company told customers

The firm disseminated its medical device correction notices by letter on 12/28/2018. The letter recommends discontinuing scanning patients in endocavity, surgical, and neonatal exams and to discontinue the use of E8C, E8CS, BE9C, BE9CS, 4DE7C, i12L, 8C, 4D8C, 7S, 5S, and 5Sp probes.

Recall number

Z-0788-2019

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

Source: FDA · Medical device enforcement report, recall number Z-0788-2019. The agency record governs; check it and the company before acting.