Events

Rappel de Kalare (DREXKL80)

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
    78166
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0012-2018
  • Date de mise en oeuvre de l'événement
    2017-09-12
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158813
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Cause
    During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
  • Action
    Toshiba planned action to bring defect into compliance: 1. You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2. You will install modified firmware on the systems to correct the defect and prevent recurrence. 3. You will provide progress reports on the effectiveness of the plan. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. Thank you for your urgent attention to this matter. If you have any questions regarding this letter please feel free to call (800) 421-1968, or contact your local Toshiba Representative at (800) 521-1968. For further questions please call (714) 730-5000.

Device

Kalare (DREXKL80)
  • Modèle / numéro de série
    Model: HDR-08A
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution
  • Description du dispositif
    Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) || Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.
  • 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