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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description 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.
Recall Number Z-1096-2013
Classification Class II
Code Info 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 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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 195873SU5 196262SU0 196269SU5 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Product Distributed Qty 2061
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 Ultrasound probe.

Event Detail

Event Id 64725
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-08
Initial Firm Notification of Consignee or Public Letter