Events

Rappel de Device Recall TSX301A/2 Aquilion One CT System

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
    63166
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2468-2012
  • Date de mise en oeuvre de l'événement
    2008-05-13
  • Date de publication de l'événement
    2012-09-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112762
  • 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
    The surestart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.
  • Action
    Toshiba American Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. customers: The firm advised customers to take the following temporary measures to avoid issues until a corrective action has been taken: I. In SureStart: " Perform scanning with Observation Direction set to VFF when the Patient Insertion Direction and Observation direction are FF. " Perform scanning with the Observation direction set to VFH when the Patient Insertion Direction and Observation Direction are HF. 2. When acquiring images for 4D perfusion analysis: " Perform scanning with the Scan Direction set to OUT when the Patient Insertion Direction and Scan Direction are HF. Perform scanning with the scan direction set to IN when the Patient Insertion Direction and Scan Direction are FF. Contact the firm at (800) 421-1968 for questions regarding this issue.

Device

Device Recall TSX301A/2 Aquilion One CT System
  • Modèle / numéro de série
    Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: MA, MD, and NV.
  • Description du dispositif
    TSX-301A/2 Aquilion One CT System. || The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. || This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
  • 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