Events

Rappel de Device Recall Aquillion One TSX301A/2D

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
    69748
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0472-2015
  • Date de mise en oeuvre de l'événement
    2014-11-05
  • Date de publication de l'événement
    2014-11-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131699
  • 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
    Potential problem with the cardiac function analysis software (cfa). incorrect analysis results may be displayed in the function parameters for the entire heart displayed as analysis results of the cfa and in a left-ventricular volume curve generated based on some of those parameters.
  • Action
    Toshiba sent an Urgent Medical Device Correction letter dated November 5, 2014, to all affected customers. Customers were asked to refrain from using the function parameters for the entire heart and the left-ventricular volume curve until corrective actions have been taken. Customers were instructed to share this information with all users and reviewing radiologist as well as clinical engineering or Biomedical group at facility. Please complete and return the attached form and fax it to the toll free number at the top of the form 877-349-3054. This form can also be sent via email to raffairs@tams.com. Revised software to prevent occurrence of this problem will be installed on the system. When the new software becomes available the Toshiba service representative will contact for an appointment to install it on the system. Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968.

Device

Device Recall Aquillion One TSX301A/2D
  • Modèle / numéro de série
    Item CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution to CA, MA, MD
  • Description du dispositif
    Cardiac Function Analysis Software || Product Data No. MPDCT0301EAD || CSCF-003A || The software is applicable to the following CT systems: || Aquilion ONE TSX-301A/2D || X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

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