GE Healthcare, LOGIQ S8 Ultrasound System 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 and neurosurgical).

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, IA, LA, MA, MI, MS, MO, MT, NE, NV, NJ, NY, NC, OH, OK, PA,RI, SC, TN, TX, VA, WA, and WI; and countries of: ALGERIA, AUSTRALIA, AUSTRIA, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, LATVIA, LEBANON, MALAYSIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, REPUBLIC OF MOLDOVIA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and YUGOSLAVIA.

Lote

Mfg Lot or Serial # 171947SU5 176566SU8 176567SU6 179458SU5 182385SU5 182653SU6 182654SU4 182656SU9 164236SU2 173818SU6 172242SU0 172243SU8 176260SU8 180632SU2 181231SU2 181232SU0 181233SU8 181234SU6 181235SU3 158763SU3 158799SU7 159780SU6 163222SU3 165600SU8 168075SU0 169495SU9 170681SU1 170893SU2 171937SU6 171941SU8 171943SU4 176123SU8 176125SU3 176129SU5 177080SU9 178951SU0 180108SU3 180110SU9 180763SU5 180766SU8 182661SU9 182379SU8 176132SU9 159604SU8 159766SU5 158247SU7 172656SU1 161686SU1 170273SU7 170272SU9 170274SU5 176924SU9 159768SU1 170197SU8 171541SU6 171540SU8 171542SU4 164268SU5 166218SU8 171371SU8 168779SU7 167274SU0 171369SU2 177085SU8 177084SU1 171370SU0 168788SU8 178593SU0 178594SU8 178595SU5 176926SU4 176925SU6 158248SU5 159963SU8 160741SU5 160742SU3 160743SU1 159964SU6 178592SU2 159965SU3 159767SU3 181434SU2 166181SU8 183107SU2 169509SU7 159792SU1 183118SU9 170672SU0 176130SU3 182380SU6 158768SU2 159776SU4 182223SU8 182222SU0 183104SU9 166172SU7 170671SU2 168080SU0 182655SU1 183102SU3 183907SU5 176939SU7 180973SU0 176938SU9 183660SU0 183661SU8 180363SU4 159246SU8 158802SU9 158805SU2 180762SU7 170669SU6 170679SU5 170683SU7 162595SU3 162592SU0 170670SU4 183108SU0 168064SU4 169487SU6 169506SU3 176121SU2 158806SU0 178022SU0 159784SU8 165587SU7 168058SU6 170676SU1 163224SU9 159789SU7 182227SU9 178023SU8 165585SU1 168056SU0 182228SU7 182376SU4 168063SU6 183105SU6 168068SU5 170675SU3 168069SU3 165588SU5 175622SU0 175623SU8 168070SU1 180761SU9 182382SU2 176136SU0 159782SU2 159783SU0 168057SU8 182230SU3 183106SU4 182378SU0 168060SU2 163225SU6 183109SU8 183110SU6 168059SU4 166185SU9 159788SU9 178018SU8 170674SU6 161687SU9 161688SU7 161689SU5 161690SU3 161691SU1 161692SU9 162593SU8 162594SU6 165584SU4 176135SU2 165583SU6 165586SU9 182377SU2 158800SU3 159793SU9 159951SU3 168074SU3 170892SU4 171944SU2 162596SU1 168071SU9 175624SU6 178027SU9 181605SU7 166178SU4 183120SU5 178026SU1 171946SU7 182224SU6 170897SU3 168073SU5 178016SU2 169502SU2 169508SU9 178029SU5 180768SU4 161694SU5 176138SU6 159249SU2 183116SU3 163230SU6 163223SU1 158759SU1 158766SU6 175617SU0 166176SU8 166177SU6 166174SU3 168055SU2 170673SU8 166180SU0 159247SU6 183113SU0 183114SU8 183115SU5 159777SU2 168838SU1 170898SU1 158767SU4 159779SU8 159778SU0 169511SU3 178038SU6 166183SU4 182221SU2 168072SU7 159781SU4 169505SU5 176128SU7 159785SU5 159786SU3 178019SU6 178020SU4 162597SU9 169493SU4 178017SU0 162599SU5 178028SU7 169510SU5 171945SU9 169513SU9 178025SU3 169503SU0 176131SU1 169504SU8 183888SU7 166179SU2 163229SU8 163231SU4 180765SU0 159775SU6 162598SU7 181433SU4 159774SU9 166175SU0 182226SU1 172890SU6 176015SU6 183119SU7 161695SU2 158764SU1 160740SU7 179387SU6 179388SU4 161696SU0 158808SU6 170894SU0 170896SU5 181432SU6 158760SU9 165598SU4 176013SU1 158807SU8 159248SU4 159244SU3 165599SU2 159251SU8 183112SU2 181431SU8 182381SU4 176122SU0 165590SU1 165589SU3 169501SU4 178021SU2 176127SU9 165591SU9 165592SU7 165593SU5 165594SU3 170895SU7 171942SU6 175618SU8 168053SU7 166279SU0 153258SU9 167283SU1 181309SU6 174785SU6 180006SU9 175346SU6 164232SU1 172855SU9 176440SU6 166275SU8 175348SU2 167282SU3 176445SU5 164237SU0 180365SU9 180005SU1 181311SU2 181308SU8 176444SU8 166282SU4 168782SU1 176443SU0 176447SU1 164238SU8 175349SU0 176441SU4 167285SU6 164233SU9 175347SU4 182435SU8 175350SU8 166280SU8 181312SU0 180000SU2 180366SU7 159608SU9 166276SU6 168787SU0 166278SU2 168786SU2 174784SU9 164239SU6 164240SU4 166274SU1 174781SU5 167277SU3 168783SU9 181314SU6 167284SU9 164235SU4 168781SU3 167286SU4 164234SU7 183468SU8 180004SU4 171934SU3 178952SU8 171933SU5 171931SU9 167278SU1 178954SU4 166281SU6 174782SU3 168780SU

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States