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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
Recall Number Z-1849-2013
Classification Class II
Code Info Mfg Lot or Serial # 223133WX0 223134WX8 223135WX5 223136WX3 223137WX1 224634WX6 224635WX3 224636WX1 224637WX9 224638WX7 224639WX5 224640WX3 224641WX1 224642WX9 224643WX7 224644WX5 224645WX2 224786WX4 224787WX2 224788WX0 224789WX8 224790WX6 224791WX4 224792WX2 224793WX0 224794WX8 224795WX5 224796WX3 224797WX1 224798WX9 224799WX7 224800WX3 224801WX1 224802WX9 224803WX7 224804WX5 224805WX2 224806WX0 224807WX8 224808WX6 224951WX4 225010WX8 225011WX6 225012WX4 225013WX2 225014WX0 225015WX7 225143WX7 225144WX5 225145WX2 225146WX0 226933WX0 226934WX8 226935WX5 226936WX3 226937WX1 227218WX5 227219WX3 227221WX9 227222WX7 227223WX5 227224WX3 227225WX0 227226WX8 227227WX6 227228WX4 227229WX2 227230WX0 227231WX8 227232WX6 227233WX4 227279WX7 227280WX5 227281WX3 227282WX1 227283WX9 227284WX7 227285WX4 227286WX2 227287WX0 227288WX8 227574WX1 227575WX8 227576WX6 227577WX4 227578WX2 228256WX4 228257WX2 228258WX0 228259WX8 228260WX6 228772WX0 228773WX8 228774WX6 228775WX3 228776WX1 228777WX9 228778WX7 228779WX5 228780WX3 229786WX9 229787WX7 229790WX1 229791WX9 229792WX7 229793WX5 231677WX6 231678WX4 231679WX2 231680WX0 231681WX8 231682WX6 231683WX4 231684WX2 231685WX9 231686WX7 231687WX5 231688WX3 231689WX1 231690WX9 232467WX1 232468WX9 232470WX5 232471WX3 232472WX1 232473WX9 232474WX7 232500WX9 232501WX7 232502WX5 232503WX3 232504WX1 232505WX8 232506WX6 233383WX9 233384WX7 233385WX4 233386WX2 233387WX0 233388WX8 233389WX6 233390WX4 233391WX2 233392WX0 233393WX8 233394WX6 233395WX3 233396WX1 234475WX2 235601WX2 235602WX0 235603WX8 235604WX6 235605WX3 236395WX0 236396WX8 236397WX6 236398WX4 236399WX2 237120WX1 237121WX9 237122WX7 237123WX5 237124WX3 237617WX6 237618WX4 237619WX2 237620WX0 237621WX8 238640WX7 238641WX5 238642WX3 238643WX1 238644WX9 240405WX1 240406WX9 240407WX7 240408WX5 240409WX3 240410WX1 240411WX9 240412WX7 240413WX5 240414WX3 240415WX0 240416WX8 242064WX4 242065WX1 242070WX1 242071WX9 242073WX5 242074WX3 242075WX0 242076WX8 242077WX6 242078WX4 242499WX2 242500WX7 242501WX5 242502WX3 242503WX1 242504WX9 242505WX6 242506WX4 242507WX2 242508WX0 242509WX8 242510WX6 242511WX4 242512WX2 242513WX0 242514WX8 242515WX5 242516WX3 242517WX1 242518WX9 237748WX9 237749WX7 225460WX5 225461WX3 225462WX1 225463WX9 225464WX7 227289WX6 227290WX4 228781WX1 229268WX8 229269WX6 229272WX0 229938WX6 229939WX4 229940WX2 229941WX0 229988WX1 234511WX4 234512WX2 234513WX0 237717WX4 237718WX2 237719WX0 237720WX8 237721WX6 237722WX4 237723WX2 241117WX1 235655WX8 237114WX4 237116WX9 224959WX7 233265WX8 237747WX1 231964WX8 237119WX3 224958WX9 227137WX7 227855WX4 228803WX3 228804WX1 228805WX8 229156WX5 229157WX3 231967WX1 233263WX3 233316WX9 234462WX0 234463WX8 234464WX6 234465WX3 234617WX9 234925WX6 234927WX2 234928WX0 234930WX6 234931WX4 235656WX6 235665WX7 235666WX5 235667WX3 237102WX9 237112WX8 237113WX6 237742WX2 237752WX1 238517WX7 216340WX0 223130WX6 223131WX4 223132WX2 224955WX5 224956WX3 224960WX5 224989WX4 224990WX2 224991WX0 227856WX2 227857WX0 227859WX6 228807WX4 228811WX6 228812WX4 228879WX3 228880WX1 228881WX9 228883WX5 229152WX4 229153WX2 229154WX0 229155WX7 229159WX9 229160WX7 229161WX5 231962WX2 231966WX3 231969WX7 231970WX5 231973WX9 231974WX7 231975WX4 231976WX2 231977WX0 231978WX8 233261WX7 233314WX4 233320WX1 233322WX7 234468WX7 234469WX5 234471WX1 234472WX9 234613WX8 234614WX6 234615WX3 234616WX1 234618WX7 234921WX5 234926WX4 235600WX4 235658WX2 235660WX8 235661WX6 235662WX4 235663WX2 235668WX1 235891WX9 235892WX7 235893WX5 235894WX3 235895WX0 237096WX3 237097WX1 237099WX7 237110WX2 237115WX1 237118WX5 237739WX8 237743WX0 237744WX8 237745WX5 237746WX3 238519WX3 238520WX1 238521WX9 224954WX8 226012WX3 226013WX1 226014WX9 226015WX6 226016WX4 226017WX2 226018WX0 226019WX8 226020WX6 226021WX4 226217WX8 226218WX6 226219WX4 226220WX2 226221WX0 226222WX8 226223WX6 226224WX4 226225WX1 226226WX9 227118WX7 227119WX5 227120WX3 227121WX1 227122WX9 227123WX7 227124WX5 227125WX2 227126WX0 227127WX8 227128WX6 227129WX4 227130WX2 227131WX0 227132WX8 227133WX6 227134WX4 227135WX1 227136WX9 227858WX8 231972WX1 233262WX5 233317WX7 233318WX5 237117WX7 237738WX0 237750WX5 237751WX3 237570WX7 241229WX4 241230WX2 226296WX2 226297WX0 226298WX8 226299WX6 226300WX2 228242WX4 228243WX2 228244WX0 228245WX7 228246WX5 232582WX7 234619WX5 235642WX6 237106WX0 237125WX0 238639WX9 239507WX7 239525WX9 239559WX8 239560WX6 240337WX6 240338WX4 240339WX2 240340WX0 240362WX4 240437WX4 240438WX2 241113WX0 241114WX8 241115WX5 241116WX3 241188WX2 227860WX4 227861WX2 227862WX0 228806WX6 231965WX5 231971WX3 233321WX9 234466WX1 234470WX3 234473WX7 234922WX3 234923WX1 234924WX9 235599WX8 237101WX1 227677WX2 227678WX0 227683WX0 227684WX8 227687WX1 227688WX9 228884WX3 228885WX0 228886WX8 229944WX4 229945WX1 229946WX9 229947WX7 229948WX5 232446WX5 232447WX3 232448WX1 232449WX9 232450WX7 232451WX5 232452WX3 233397WX9 233398WX7 233399WX5 233657WX6 233658WX4 233659WX2 233660WX0 234932WX2 234933WX0 235596WX4 235643WX4 235644WX2 235645WX9 236233WX3 236234WX1 236235WX8 236236WX6 236237WX4 236238WX2 236239WX0 237544WX2 237545WX9 237546WX7 237547WX5 237548WX3 238645WX6 238646WX4 238647WX2 238648WX0 238649WX8 238650WX6 238651WX4 239526WX7 239527WX5 239528WX3 239529WX1 239571WX3 239572WX1 239573WX9 239574WX7 240363WX2 241178WX3 241179WX1 241180WX9 241181WX7 241182WX5 241183WX3 241184WX1 241185WX8 241232WX8 241249WX2 241250WX0 241251WX8 241252WX6 241613WX9 241614WX7 241615WX4 241616WX2 241617WX0 242355WX6 242356WX4 227863WX8 227864WX6 231961WX4 229270WX4 229271WX2 229942WX8 229943WX6 232570WX2 232571WX0 232572WX8 234514WX8 228810WX8 231968WX9 237103WX7 237108WX6 237109WX4 234467WX9 237111WX0 233319WX3 235664WX0 229608WX5 229609WX3 238638WX1 228808WX2 231959WX8 231960WX6 233264WX1 233313WX6 224957WX1 228882WX7 235659WX0 238518WX5 216341WX8 235654WX1 235657WX4 229158WX1 233315WX1 235598WX0 237740WX6 237741WX4 228809WX0 231963WX0 234929WX8 237098WX9 237100WX3
Product Distributed Qty 588
Reason For Recall GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.

Event Detail

Event Id 65759
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-09
Initial Firm Notification of Consignee or Public Visit
Distribution Pattern Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the countries of ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, INDIA, ITALY, JAPAN, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND and UNITED EMIRATES.
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