Events

Rappel de Toshiba Aquilion Prime

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 Toshiba American Medical Systems Inc.

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
    75661
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0622-2017
  • Date de mise en oeuvre de l'événement
    2016-10-25
  • Date de publication de l'événement
    2016-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151012
  • 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
    Toshiba american medical systems (tams) is recalling the aquilion ct system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.
  • Action
    Toshiba American Medical Systems, Inc. sent an Urgent Medical Device Correction letter dated October 25, 2016, to all affected customers who received the Aquilion CT system to inform them that Toshiba America Medical System has received reports that the cooling oil in the x-ray tube heat exchanger may leak during system operation. The letter informs the customers of the description found and corrective action. Customers were instructed to complete the attached customer reply form and fax it to (877) 349-3054 or send it to raffairs@tams.com. Customers with questions are instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968. For questions regarding this recall call 714-730-5000.

Device

Toshiba Aquilion Prime
  • Modèle / numéro de série
    5LA1392001 5LA1392002 5LA1392004 5LA13X2005 5LA13X2006 5LA13X2007 5LA13X2008 5LA13X2010 5LA13Y2011 5LA13Y2012 5LA13Y2013 5LA13Y2014 5OA13Y2015 5OA13Y2016 5LA13Y2017 5DA13Z2018 5LA13Z2019 5LA13Z2020 5LA13Z2021 5LA13Z2022 5LA13Z2023 5LA13Z2024 5LA13Z2025 5DA13Z2026 5LA13Z2027 5LA1412028 5LA1412029 5LA1412030 5LA1412031 5DA1422032 5LA1422033 5DA1422034 5LA1422035 5LA1422036 5LA1422037 5DA1422038 5LA1422039 5GA1422040 5OA1422041 5DA1422042 5DA1422043 5OA1422044 5DA1432045 5LA1432046 5DA1432047 5GA1432048 5LA1442050 5DA1442051 5LA1442052 5OA1442053 5DA1442054 5LA1452055 5DA1452056 5DA1452057 5DA1452058 5DA1452059 5LA1452060 5OA1452061 5LA1452062 5DB1462063 5LB1462064 5LB1462065 5DB1462066 5LB1462067 5GB1462068 5DB1462069 5DB1462070 5DB1462071 5DB1462072 5DB1472073 5DB1472074 5LB1472075 5LB1472076 5LB1472077 5OB1472078 5LB1472080 5LB1482081 5DB1482082 5DB1482083 5LB1482084 5LB1482085 5DB1482086 5DB1482087 5DB1482088 5DB1492089 5DB1492090 5LB14X2091 5DB14X2092 5GB14X2093 5LB14X2094 5LB14X2096 5GB14X2097 5LB14X2098 5LB14X2099 5LB14X2100 5DB14Y2101 5DB14Y2102 5LB14Y2103 5GB14Y2104 5DB14Y2105 5DB14Y2106 5DB14Y2107 5LB14Y2108 5LB14Y2109 5DB14Z2110 5DB14Z2111 5DB14Z2112 5LB14Z2113 5GB14Z2114 5LB14Z2115 5LB14Z2116 5DB14Z2117 5DB14Z2118 5DB14Z2119 5LB14Z2120 5DB14Z2121 5DB14Z2122 5DB14Z2123 5GB14Z2124 5DB14Z2125 5DB1512126 5DB1512127 5LB1512128 5LB1512129 5DB1512130 5DB1512131 5DB1512132 5DB1512133 5GB1512134 5LB1512135 5OB1512136 5DB1512137 5DB1522138 5DB1522139 5DB1522140 5DB1522141 5GB1522142 5LB1522143 5DB1522144 5DB1522145 5DB1522146 5DB1522147 5GB1522148 5DB1522149 5DB1522150 5DB1522151 5DB1522152 5LB1542153 5GB1542154 5LB1542155 5LB1542156 5GB1542157 5LB1542158 5OB1542159 5GB1542160 5LB1542161 5LB1542162 5LB1552163 5LB1552164 5DB1552165 5LB1552166 5LB1552167 5DB1552168 5LB1552169 5DB1562170 5DB1562171 5LB1562172 5OB1562173 5DB1562174 5LB1562175 5LB1562176 5LB1562177 FLB1572001 FLB1572002 FLB1572003 FLB1572004 FLB1572005 FLB1572006 FLB1572007 FLB1572008 FLB1572009 FLB1572010 FLB1572011 FLB1572012 FLB1572013 FLB1582014 FLB1582015 FLB1582017 FLB1582018 FOB1582019 FOB1582020 FLB1582021 FLB1582022 FLB1582023 FLB1592024 FLB1592025 FLB1592026 FLB1592027 FLB15X2028 FLB15X2029 FLB15X2030 FLB15X2031 FOB15X2032 FLB15X2033 FLB15X2034 FLB15X2035 FLB15Y2036 FLB15Y2037 FLB15Y2038 FOB15Y2039 FOB15Y2040 FLB15Y2041 FOB15Y2042 FOB15Y2043 FLB15Y2044 FLB15Y2045 FLB15Y2046 FLB15Z2047 FLB15Z2048 FLB15Z2049 FLB15Z2050 FLB15Z2051 FLB15Z2052 FLB15Z2053 FLB15Z2054 FLB15Z2055 FLB15Z2056 FLB15Z2057 FLB1612058 FLB1612059 FLB1612060 FLB1612061 FLB1612062 FLB1612063 FLB1612064 FLB1612065 FLB1612066 FLB1612067 FLB1612068 FOB1612069 FLB1622070 FLB1622071 FOB1622072 FLB1622073 FLB1622074 FLB1622075 FLB1622076 FLB1622077 FLB1622078 FLB1632079 FLB1632080 FLB1632081 FLB1632082 FLB1632083 FLB1632084 FLB1642085 FLB1642086 FLB1642087 FLB1642088 FLB1642089 FLB1642090 FLB1642091 FLB1642092 FLB1642093 FLB1652094 FLB1652095 FLB1652096 FLB1652097 FLB1652098 FOB1652099 FLB1652100 FLB1652101 FLB1652102 FLB1652103 FLB1652104 FLB1652105 FLB1662107 FLB1662108 FOB1662109 FOB1662110 FLB1662111 FLB1662112 FLB1662113 FLB1672115 FLB1682116 FLB1682117 FOB1682118 FLB1682119 FLB1682120 FLB1692123 5LA1392003 5LA1432049 5LA13X2009 5LB14X2095 FLB1582016 FLB1662106 FLB1662114 FLB1682121 FOB1682122
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Aquilion Prime TSX-303A || Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Adresse du fabricant
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA