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.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

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.

Lote

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 198943SU

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States