Events

Rappel de Device Recall CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Medical Systems, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    52022
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1720-2009
  • Date de mise en oeuvre de l'événement
    2009-05-04
  • Date de publication de l'événement
    2009-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81921
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    Ge healthcare has recently become aware of the need to adjust default settings associated with the use of ct perfusion 4 on the advantage workstation, st and pet/ct consoles that may impact patient safety. the default parameter settings in ct perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (isd) greater th.
  • Action
    GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 23, 2009. The letter was addressed to Hospital Administrators / Risk managers and Radiology department mangers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information instructing the user to follow the enclosed User Guide Addendum to mitigate further problems. For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan); for other countries, contact your local GE Healthcare field service representative.

Device

Device Recall CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles
  • Modèle / numéro de série
    Serial Numbers: 00000152741GE5, 00000152737GE3, 00000134590GE9, 00000119522GE1, 00000119523GE9, 00000146655GE6, 00000146668GE9, 00000146669GE7, 00000119519GE7, 00000145765GE4, 00000152738GE1, 00000121182GE0, 00000122793GE3, 00000119517GE1, 00000139086GE3, 00000141801GE1, 00000141802GE9, 00000141803GE7, 00000141804GE5, 00000141805GE2, 00000119521GE3, 00000118133GE8, 00000118134GE6, 00000118135GE3, 00000121180GE4, 00000141807GE8, 00000119516GE3, 00000123926GE8, 00000123931GE8, 00000122794GE1, 00000127524GE7, 00000127525GE4, 00000129247GE3, 00000134588GE3, 00000123927GE6, 00000123929GE2, 00000119520GE5, 00000122797GE4, 00000122795GE8, 00000123930GE0, 00000127522GE1, 00000127523GE9, 00000129243GE2, 00000127520GE5, 00000127521GE3, 00000127526GE2, 00000139088GE9, 00000129246GE5, 00000145645GE8, 00000141808GE6, 00000141811GE0, 00000151783GE8, 100995344, 00000145642GE5, 00000145647GE4, 00000118132GE0, 00000122799GE0, 00000122800GE6, 00000123928GE4, 00000127519GE7, 00000152735GE7, 00000129244GE0, 00000129245GE7, 00000129248GE1, 00000129249GE9, 00000129250GE7, 00000129251GE5, 00000134584GE2, 00000134585GE9, 00000134586GE7, 00000134587GE5, 00000145649GE0, 00000152742GE3, 00000122798GE2, 100995241, 100995217, 100995259, 80521349, 100995302, 100995275, 100995276, 100995431, 100995326, 100995412, 100995322, 80515302, 80515303, 80523248, 100995352, 100995298, 100995359, 100995306, 100995268, 100995354, 0CC08041501002, 0CC08041501003, 100995225, 80528332, 80521354, 100995279, 100995280, 100995281, 100995282, 100995283, 100995297, 100995305, 100995308, 100995288, 100995340, 100995355, 100995361, 100995385, 100995356, 100995450, 100995227, 80528736, 0CC08041501009, 80528724, 100995242, 100995351, 100995211, 100995212, 100995383, 80527216, 80527225, 80515730, 80528335, 80515721, 80521344, 80528730, 80528741, 80521352, 80521350, 80523251, 80521348, 100995222, 80515722, 100995339, 00000134592GE5, 00000134591GE7, 80505225, 80505229, 0CC08041501005, 80528328, 80528336, 80529188, 80521353, 100995224, 100995218, 100995221, 100995360, 100995240, 100995266, 100995267, 100995274, 80528329, 80528327, 00000121178GE8, 00000141809GE4, 00000152739GE9, 00000155218GE1, 00000121179GE6, 0CC08041501008, 100995239, 100995294, 100995327, 80528734, 100995366, 80515727, 80528322, 80521355, 100995278, 100995328, 100995331, 100995396, 100995411, 100995420, 00000146658GE0, 80528723, 80528324, 80505223, 80505226, 80505228, 100995220, 80528325, 0CC08041501007, 80527223, 80515296, 80528731, 80527219, 100995408, 0CC08041501010, 80528733, 80528735, 80528732, 80529189, 80521356, 100995311, 100995364, 100995219, 100995271, 100995292, 100995338, 100995334, 100995336, 100995286, 100995350, 100995379, 100995317, 100995318, 100995413, 100995449, 100995375, 80523250, 80515297, 80521351, 80528326, 0CC08041501004, 100995205, 80521343, 0CC08041501001, 100995270, 80505230, 80527218, 100995265, 100995300, 100995400, 100995426, 100995433, 80527224, 100995330, 100995341, 100995378, 100995291, 80528323, 0CC08041501006, 80505227, 100995377, 100995295, 100995272, 100995312, 100995368, 100995284, 100995349, 100995245, 80528330, 100995289, 100995255, 100995256, 100995374, 100995406, 100995319, 100995415, 100995409, 100995401, 100995332, 100995325, 100995419, 100995405, 100995407, 100995427, 100995429, 100995417, 80523253, 80528333, 00000145766GE2, 00000145644GE1, 80515298, 100995260, 0CC08040101001, 100995249, 100995388, 100995425, 100995229, 80523247, 100995209, 80528337, 100995296, 80515724, 80528339, 80505231, 80528739, 80515723, 80528340, 80515725, 80529195, 100995244, 80523249, 80515728, 80515729, 100995348, 100995370, 100995410, 100995376, 80529190, 80529191, 80529192, 80515726, 80529186, 80523246, 80528338, 80527222, 80529194, 80529193, 80528725, 80521346, 80528331, 80528334, 80528321, 80521347, 100995250, 100995251, 100995252, 100995254, 100995342, 000005189396-2, 100995223, 80523252, 100995215, 100995236, 100995231, 100995233, 100995232, 100995234, 100995237, 100995230, 100995235, 100995247, 100995304, 100995269, 100995273, 100995258, 100995285, 100995337, 100995287, 100995246, 100995314, 100995264, 100995387, 100995343, 100995365, 100995390, 100995392, 100995394, 100995391, 100995393, 100995384, 100995329, 100995404, 100995395, 100995402, 80528740, 80528737, 80527217, 80527221, 80528726, 80528727, 80528728, 100995316, 100995345, 100995353, 100995367, 80505224, 80505232, 100995207, 00000146661GE4, 00000144815GE8, 00000146660GE6, 00000146662GE2, 100995418, 100995441, 100995416, 00000146664GE8, 00000146666GE3, 00000146665GE5, 00000146659GE8, 100995238, 80529187, 100995208, 80523254, 100995214, 100995213, 100995206, 80515301, 80515305, 80527220, 100995253, 80523255, 100995210, 80515299, 80515304, 100995226, 100995257, 100995323, 100995228, 100995248, 100995262, 100995362, 100995301, 100995307, 100995309, 100995310, 100995299, 100995346, 100995403, 100995373, 100995363, 100995389, 100995422, 100995380, 100995381, 100995434, 00000145763GE9, 00000134589GE1, 00000121181GE2, 00000119518GE9, 00000151784GE6, 00000134583GE4, 00000141810GE2, 00000145641GE7, 00000145640GE9, 00000145768GE8, 00000145764GE7, 00000145767GE0, 00000151782GE0, 00000139087GE1, 00000145643GE3, 00000151780GE4, 00000151781GE2, 00000152740GE7, 00000152736GE5, 00000145646GE6, 00000145648GE2, 100995263, 100995243, 100995261, 100995421, 100995436, 100995435, 100995423, 100995424, 00000118131GE2, 00000141806GE0 and 00000118136GE1.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Including states of AZ, CA, CT, DC, FL, HI, IL, IA, MA, MI, NJ, NY, NC, OK, PA, PR, TX, WA, WV and WI and countries of ARGENTINA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PAKISTAN, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM and VENEZUELA.
  • Description du dispositif
    GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. || Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Adresse du fabricant
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA