Events

Rappel de Device Recall TSX101: Aquilion 32/64

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
    59519
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3221-2011
  • Date de mise en oeuvre de l'événement
    2010-12-08
  • Date de publication de l'événement
    2011-09-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103009
  • 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
    There is the potential that the current may not be controlled correctly in examinations using the ecg modulation function, which adjusts the x-ray output in synchronization with the ecg waveform.
  • Action
    Toshiba America Medical Systems (TAMS) issued an Urgent: Medical Device Correction notification to consignees via USPS return receipt mail. The letter identified the affected product, the problem, and corrective action. The firm plans to install revised firmware to prevent the occurrence of the problem. A Toshiba Service Representative will contact customers to schedule an appointment for installation. The firm asked customers to stop using the Power Reduction option during ECG modulated scanning until the new firmware has been installed. Customers are to share the information in the letter with all users, reviewing radiologist, and the clinical engineering or Biomedical group at their facility. Customers are also to complete and return the attached reply form via fax or e-mail to TAMS as proof of notification. Questions pertaining to the letter should be directed to 800-421-1968 or customers' local Toshiba Representative at 800-521-1968.

Device

Device Recall TSX101: Aquilion 32/64
  • Modèle / numéro de série
    Units manufactured from January 2005 to September 2007
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.
  • 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 92781-2068
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA