FDAFDA · Alimentos y medicamentos·N.º oficial Z-1849-2013
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.
Publicado el 7 de agosto de 2013 · Inicio del retiro: 9 de noviembre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- 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.
- Lote
- 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 238521WX
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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