Devices

Device Recall Signa Excite

  • 모델명 / 제조번호(시리얼번호)
    SERIAL  00000277692MR0 00000276632MR7 00000280465MR6 00000284315MR9 00000276732MR5 00000280892MR1 00000280464MR9 00000281796MR3 00000278623MR4 00000278196MR1 00000275595MR7 00000281935MR7 00000278626MR7 00000282909MR1 00000280461MR5 00000283074MR3 00000274891MR1 00000279922MR9 00000282548MR7 00000281267MR5 00000273517MR3 00000281020MR8 00000280954MR9 00000282105MR6 00000283998MR3 00000285302MR6 00000281346MR7 00000279502MR9 00000285599MR7 00000273536MR3 00000281185MR9 00000281312MR9 00000281456MR4 00000283663MR3 00000273487MR9 00000280009MR2 00000282253MR4 00000280276MR7 00000279925MR2 00000279887MR4 00000278472MR6 00000281445MR7 00000276633MR5 00000283316MR8 00000276728MR3 00000282695MR6 2284300 00000273537MR1 00000283452MR1 00000283468MR7 00000273265MR9 00000283345MR7 00000284360MR5 00000287579MR7 00000278245MR6 00000279503MR7 00000279078MR0 00000280435MR9 00000282830MR9 00000283077MR6 00000283653MR4 00000283437MR2 00000281681MR7 00000278622MR6 00000280620MR6 00000274711MR1 00000281022MR4 00000274713MR7 00000281314MR5 00000281273MR3 00000280274MR2 00000283665MR8 00000279915MR3 00000283365MR5 00000277599MR7 00000281265MR9 00000027862MR0 00000283530MR4 00000273541MR3 00000284786MR1 00000275937MR1 00000274937MR2 00000287317MR2 00000283624MR5 00000282788MR9 00000273516MR5 00000277763MR9 00000278726MR5 00000281227MR9 00000277965MR0 00000280094MR4 00000281347MR5 00000276330MR8 00000283377MR0 00000279076MR4 00000274717MR8 00002181458MR0 00000276735MR8 00000274931MR5 00000274170MR0 00000282463MR9 00000286406MR4 00000282524MR8 00000277788MR6 00000281937MR3 00000027888MR3 00000287864MR3 00000277959MR3 00000283151MR9 00000280278MR3 00000279627MR4 00000283473MR7 00000274930MR7 00000278619MR2 00000278246MR4 00000277700MR1 00000274889MR5 00000274933MR1 00000282849MR9 00000283471MR1 00000273514MR0 00000276737MR4 00000278561MR6 00000274939MR8 00000287086MR3 00000282812MR7 00000282492MR8 00000281457MR2 00000284903MR2 00000281526MR4 00000285664MR9 00000281776MR5 00000281703MR9 00000281188MR3 00000280374MR0 00000286309MR0 00000280462MR3 00000281442MR4 00000275597MR3 00000281829MR2 00000274709MR5 00000275474MR5 00000287063MR2 00000282792MR1 00000287617MR5 00000280069MR6 00000286391MR8 00000282107MR2 00000282106MR4 00000281644MR5 00000285951MR0 00000275936MR3 00000281678MR3 00000275938MR9 00000289205MR7 00000282857MR2 00000283506MR4 00000280767MR5 00000286526MR9 00000280095MR1 00000282961MR2 00000281266MR7 00000286425MR4 00000273008MR3 00000281840MR9 00000283435MR6 00000280434MR2 00000279080MR6 00000280526MR5 00000282080MR1 00000286282MR9 00000283317MR6 00000279892MR4 00000286476MR7 00000280903MR6 00000283357MR2 00000283385MR3 00000285384MR4 00000287396MR6 00000274892MR9 00000283696MR3 00000285023MR8 00000286267MR0 00000283474MR5 00000282911MR7 00000284214MR4 00000275475MR2 00000286149MR0 00000275736MR7 00000283697MR1 00000277600MR3 00000289162MR0 00000286250MR6 00000280619MR8 00000281056MR2 00000280713MR9 00000280759MR2 00000281313MR7 00000275473MR7 00000281865MR6 00000281857MR3 00000278307MR4 00000282079MR3 00000283150MR1 00000285301MR8 00000283755MR7 00000282464MR7 00000282958MR8 00000282083MR5 00000273009MR1 00000282029MR8 00000274710MR3 00000274150MR2 00000275935MR5 00000276332MR4 00000282084MR3 00000283300MR2 00000285914MR8 00000285300MR0 00000286060MR9 00000286058MR3 00000286061MR7 00000278463MR5 00000277602MR9 00000284236MR7 00000285020MR4 00000276276MR3 00000276273MR0 00000288212MR4 00000273518MR1 00000286146MR6 00000279077MR2 00000274708MR7 00000278305MR8 00000273267MR5 00000272999MR4 00000274169MR2 00000275735MR9 00000275599MR9 00000275737MR5 00000274173MR4 00000279404MR8 00000273489MR5 00000277961MR9 00000284464MR5 00000287399MR0 00000278469MR2 00000279407MR1 00000283358MR0 00000283576MR7 00000276631MR9 00000284296MR1 00000283792MR0 00000293589MR8 00000282730MR1 00000275738MR3 00000284337MR3 00000281858MR1 00000278613MR5 00000283039MR6 00000277863MR7 00000281866MR4 00000278558MR2 00000280273MR4 00000290775MR6 00000284297MR9 00000286145MR8 00000280004MR3 00000286281MR1 00000284279MR7 00000278621MR8 00000278748MR9 00000284642MR6 00000274936MR4 00000278468MR4 00000282682MR4 00000280769MR1 00000281344MR2 00000278304MR1 00000284355MR5 00000278195MR3 00000274171MR8 00000280432MR6 00000279630MR8 00000293588MR0 00000274890MR3 00000287850MR2 00000273006MR7 00000273540MR5 00000282959MR6 00000282686MR5 00000281704MR7 00000276731MR7 00000280768MR3 00000283470MR3 00000286392MR6 00000287810MR6 00000274166MR8 00000289004MR4 00000287879MR1 00000288901MR2 00000283386MR1 00000282501MR6 00000288667MR9 00000293587MR2 00000285172MR3 00000282791MR3 00000283526MR2 00000282790MR5 00000288244MR7 00000286559MR0 00000285019MR6 00000278749MR7 00000277601MR1 00000280898MR8 00000280951MR5 00000285380MR2 00000283761MR5 00000286800MR8 00000289798MR1 00000288811MR3 00000282088MR4 00000284787MR9 00000285222MR6 00000276635MR0 00000280005MR0 00000283378MR8 00000286538MR4 00000280621MR4 00000285303MR4 00000282831MR7 00000283174MR1 00000286897MR4 00000284644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R4 00000276250MR8 00000272078MR7 00000261675MR3 00000272535MR6 00000275095MR8 00000269339MR8 00000272346MR8 00000263263MR6 00000263264MR4 00000267326MR7 00000271122MR4 00000276418MR1 00000270384MR1 00000272336MR9 00000278842MR0 00000261200MR0 00000261065MR7 00000262931MR9 00000262801MR4 00000264741MR0 00000265179MR2 00000267973MR6 00000267977MR7 00000271126MR5 00000266147MR8 00000267037MR0 00000279159MR8 00000280302MR1 00000262803MR0 00000277194MR7 00000279751MR2 00000270974MR9 00000272893MR9 00000262664MR6 00000273229MR5 00000274996MR8 00000260625MR9 00000265590MR0 00000273676MR7 00000277190MR5 00000272894MR7 00000277583MR1 00000279802MR3 00000264089MR4 00000274688MR1 00000277487MR5 00000265593MR4 00000273223MR8 00000275091MR7 00000277189MR7 00000279752MR0 00000279458MR4 00000280299MR9 00000267809MR2 00000261198MR6 00000267650MR0 00000261206MR7 00000272432MR6 00000266072MR8 00000279482MR4 00000274074MR4 00000270563MR0 00000238361MR3 00000270572MR1 00000270631MR5 00000264747MR7 00000266345MR8 00000272102MR5 00000269572MR4 00000264742MR8 00000261679MR5 00000264088MR6 00000265866MR4 00000269379MR4 00000272335MR1 00000276493MR4 00000260628MR3 00000264740MR2 00000267323MR4 00000265594MR2 00000268421MR5 00000275094MR1 00000267807MR6 00000272532MR3 00000029079MR2 00000266713MR7 00000290984MR4 00000029464MR7 00000280313MR8 00000265966MR4 00000269583MR1 00000280724MR6 00000271052MR3 00000263314MR7 00000265801MR1 00000266043MR9 00000268371MR2 00000275097MR4 000A0000012MR2 00000290961MR2 00000275469MR5 00000241749MR1 00000266129MR6 00000280723MR8 00000280046MR4 00000264693MR3 00000269393MR5 00000291209MR5 00000270266MR0 00000269792MR8 00000295454MR3 00000291666MR6 00000289771MR8 00000286629MR1 00000286299MR3 00000280098MR5 00000270607MR5 00000281225MR3 00000263935MR9 1 00000227408MRI 00000264599MR2 00000227571MR7 00000279874MR2 00000270550MR7 00000270321MR3 00000271141MR4 00000266011MR6 00000267359MR8 00000228289MR3 00000296210MR8 00000266838MR2 00000265687MR4 0 00000290528MR9 00000263660MR3 00000292604MR6 00000266009MR0 00000266161MR9 0000266161MR9A 00000026584MR6 00000265968MR8 00000266214MR6 00000281077MR8 00000271753MR6 00000295451MR9 151 00000275023MR0 00000293024MR6 00000269359MR6 00000266740MR0 00000271656MR1 00000269061MR8 00000265939MR9 00000268672MR3 00000029027MR9 00000029187MR8 00000280946MR5 00000263603MR3 00000237968MR3 00000289882MR3 00000296420MR3 00000275920MR7 00000283249MR1 104 00000271269MR3 00000283321MR8 00000271776MR7 00000266605MR5 00000271268MR5 00000266837MR4 00000275062MR8 00000266457MR1 00000000BYV7UN 00000268745MR7 00000268049MR4 00000296638MR0 00000283464MR6 00000291910MR8 00000271055MR6 00000290712MR9 00000266764MR0 00000267646MR8 00000269483MR4 00000270381MR7 00000294646MR5 00000293706MR8 00000291852MR2 00000269392MR7 00000296098MR7 00000267728MR4 00000266162MR7 00000269584MR9 00000278364MR5 00000271049MR9 00000276436MR3 00000271780MR9 00000026397MR9 00000268501MR4 00000271139MR8 00000268359MR7 00000295558MR1 00000266442MR3 00000027974MR5 00000268306MR8 00000272973MR9 00000276370MR4 00000266653MR5 00000265579MR3 00000291254MR1 00000295221MR6 00000268453MR8 00000265960MR5 00000251871MR0 00000274180MR9 00000285956MR9
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including DC and PR; and countries including: VIET NAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, FORMER YUGOSLAV REPUBLIC OF MACEDONIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, REPUBLIC OF KOREA, PORTUGAL POLAND, PHILIPPINES, PERU,PARAGUAY, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MAURITIUS, MARTINIQUE,MALTA, MALAYSIA, LUXEMBOURG,LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, KENYA, KAZAKHSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUYANA, GUATEMALA, GUADELOUPE, GREECE, GERMANY, GEORGIA, FRENCH POLYNESIA, FRANCE, FINLAND, EL SALVADOR, EGYPT, ECUADOR, DOMINICAN REPUBLIC, DENMARK, CECH REPUBLIC, CYPRUS, CROATIA, COLOMBIA, CHINA, CHILE, CANDA, BULGARIA, BRAZIL, BOSNIA AND HERZEGOVINA, BOLIVIA, BELGIUM, BELARUS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
  • 제품 설명
    6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) || Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T) || The GE Signa¿ HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, 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¿ HDe system 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.
  • Manufacturer
    GE Healthcare, LLC
  • 1 Event

제조사

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Signa Excite" 1.5 T Magnetic Resonance Systems, GE Healthcare, P.O. Box 44 Milwau...
  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Throughout USA except states of AK, VT and WY, and the countries of: Argentina, Australia, Bulgaria, Brazil, China, Canada, Switzerland, Chile, Colombia, Czech Republic, Ecuador, Egypt, Spain, Finland, France, Great Britain, Guatemala, Honduras, Croatia, Hungary, Indonesia, Ireland, India, Iran, Iceland, Italy, Japan, Kenya, South Korea, Kuwait, Lebanon, Luxembourg, Libya, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Puerto Rico, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Syria, Thailand, Tunisia, Turkey, Taiwan, Venezuela, and South Africa.
  • 제품 설명
    Signa¿ Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.
  • Manufacturer
    GE Healthcare, LLC
Device Recall Signa Excite 1.5 T (Excite II)
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including DC and PR; and countries including: VIET NAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, FORMER YUGOSLAV REPUBLIC OF MACEDONIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, REPUBLIC OF KOREA, PORTUGAL POLAND, PHILIPPINES, PERU,PARAGUAY, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MAURITIUS, MARTINIQUE,MALTA, MALAYSIA, LUXEMBOURG,LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, KENYA, KAZAKHSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUYANA, GUATEMALA, GUADELOUPE, GREECE, GERMANY, GEORGIA, FRENCH POLYNESIA, FRANCE, FINLAND, EL SALVADOR, EGYPT, ECUADOR, DOMINICAN REPUBLIC, DENMARK, CECH REPUBLIC, CYPRUS, CROATIA, COLOMBIA, CHINA, CHILE, CANDA, BULGARIA, BRAZIL, BOSNIA AND HERZEGOVINA, BOLIVIA, BELGIUM, BELARUS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
  • 제품 설명
    9) Signa Excite 1.5 T (Excite II) || (K013636 Signa Infinity MR System with EXCITE Technology) || Signa Infinity MR System with EXCITE || (K013636 Signa Infinity MR System with EXCITE Technology) || 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.
  • Manufacturer
    GE Healthcare, LLC