SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Worldwide distribution: USA (nationwide) including DC and Puerto Rico and countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIDJAN, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIAN, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU. PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF MACEDONIA, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TUR,EKY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, YUGOSLAVIA, MALAWI, MAURITANIA, NIGERIA, UKRAINE, IVORY COST, OMAN, ZAMBIA, UZBEKISTAN, ESTONIA, IRAQ, and JAMAICA.

Lote

Ref. # 60808 "Products: Signa Infinity MR System with EXCITE Technology, Signa EXCITE 1.5T and Signa EXCITE 3.0T, Signa 3T with EXCITE, Signa 3T Infinity with EXCITE, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (Waukesha, WI) FMI 60808" Mfg Lot or Serial # 00000298045MR6 00000237944MR4 00000278301MR7 00000257724MR5 00000029079MR2 00000280678MR4 00000286982MR4 00000283664MR1 00000263686MR8 00000238343MR8 00001011BD6649 00000105XF5011 00000263832MR8 00000256696MR6 00000284409MR0 00000265824MR3 00000284407MR4 00000252930MR3 00000301212MR7 00000277495MR8 00000238364MR4 00000230664MR5 00000262150MR6 00000275961MR1 00000231910MR1 00000284466MR0 00000276678MR0 00000006583YR9 00000262101MR9 00000283815MR9 00000268471MR0 00000028886MR2 00000297726MR2 00000277916MR3 00000290478MR7 00000247217MR3 00000245819MR8 00000284864MR6 00000287026MR9 00000238355MR2 00000265183MR4 00000266460MR5 00000251094MR9 00000266825MR9 00000265718MR7 00000289270MR1 00000288702MR4 00000286851MR1 00000281374MR9 000000HDMR2685 00000HDMR20256 00000236703MR5 00000297201MR6 00000234797MR9 00000265066MR1 00000278766MR1 00000255610MR8 00000280252MR8 00000281156MR0 00000011742YR4 00000011570YR9 00000279479MR0 00000009057YR1 00000284902MR4 00000287649MR7 00000239864MR2 00000235678MR0 00000241145MR2 00000255599MR3 00000028959MR7 00000235242MR5 00000257752MR6 00000256990MR3 00000275647MR6 00000246615MR9 00000300674MR9 00000011579YR0 00000286249MR8 00000279921MR1 00000011882YR8 00000262908MR7 00000271646MR2 00000290192MR4 00000254485MR6 00000259530MR4 00000288192MR8 00000245803MR2 00000246622MR5 00000278624MR2 00000261879MR1 00000937BD5ED5 00000301020MR4 00000289016MR8 00000229365MR2 00000232415MR0 00000256228MR8 00000264529MR9 00000298718MR8 00000284386MR0 00000276588MR1 00000242558MR5 00000253635MR7 00000256984MR6 00000287626MR6 00000280089MR4 00000256699MR0 00000260698MR6 00000262933MR5 00000272896MR2 00000272890MR5 00000237064MR1 00000005232YR4 00000233272MR4 00000299162MR8 00000229474MR2 00000248485MR5 00000268524MR6 00000237059MR1 00000285218MR4 00000011910YR7 00000266754MR1 00000286785MR1 00000301356MR2 00000299828MR4 00000241868MR9 00000273672MR6 00000262458MR3 00000228289MR3 00000257732MR8 00000286701MR8 00000278873MR5 00000244845MR4 00000291805MR0 00000283949MR6 00000230694MR2 00000242548MR6 00000241866MR3 00000289771MR8 00000292635MR0 00000278669MR7 00000279078MR0 00000235690MR5 00000286843MR8 00000270976MR4 00000269336MR4 00000260699MR4 00000012244YR0 00000266828MR3 00000260864MR4 00000272284MR1 00000273632MR0 00000279874MR2 00000284640MR0 00000258090MR0 00000300909MR9 00000249768MR3 00000272283MR3 00000286016MR1 00000283849MR8 00000296144MR9 00000279405MR5 00000287081MR4 00000302511MR1 00000251241MR6 00000283682MR3 00000274745MR9 00000234794MR6 00000255208MR1 00000262151MR4 00000279483MR2 00000933BD5E06 00000239042MR5 00001008BD6517 00000235236MR7 00000280524MR0 00000267180MR8 00000284599MR8 00000270386MR6 00000HDMR20043 00000287846MR0 00000268283MR9 00000269380MR2 00000235680MR6 00000251800MR9 00000294406MR4 00000245809MR9 00000255571MR2 00000264617MR2 00000265964MR7 00000234855MR5 00000HDMR20069 00000273541MR3 00000278688MR7 00000277575MR7 00000284709MR3 00000011508YR9 00000277494MR1 00000248159MR6 00000282788MR9 00000239241MR3 00000278291MR0 00000278391MR8 00000919BD5B98 00000265720MR3 00000231911MR9 00000241865MR5 00000261877MR5 00000255569MR6 00000950BD6297 00000296292MR6 00000243702MR8 00000010163YR4 00000260470MR0 00000290052MR0 00000012162YR4 00000288015MR1 00000280000MR1 00000266799MR6 00000275583MR3 00000272627MR1 00000231913MR5 00000300799MR4 00000276634MR3 00000244846MR2 00000251231MR7 00000024170MR6 00000243700MR2 00000262464MR1 00000008345YR1 00000239857MR6 00000260626MR7 00000275653MR4 00000281157MR8 00000270462MR5

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States