Events

Rappel de Device Recall Toshiba DRAD3000E FPD Wireless 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
    73064
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1175-2016
  • Date de mise en oeuvre de l'événement
    2016-01-14
  • Date de publication de l'événement
    2016-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142948
  • 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
    When a user performed radiography using the wireless fpd, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. it also indicated to select the "ok" button to re-acquire the image data or to select the¿'cancel" button to cancel the re-acquisition. as instructed the user selected "ok" and the same message window appeared. this same operation was repeated several times with the identical result - no image. finally, the user selected "cancel" and the re-acquisition was terminated.
  • Action
    Toshiba's planned action: 1."Toshiba America Medical Systems, Inc. (TAMS) will advise contact customers to stop using the system if any abnormalities are found using the system. 2. TAMS will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that TAMS will without charge, remedy the defect or bring the product into compliance. 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 noted below are to be included in the notification. 2. TAMS will implement this CAP by June 30, 2016. Customers with questions were advised to call 301-796-5910. For questions regarding this recall call 714-730-5000.

Device

Device Recall Toshiba DRAD3000E FPD Wireless system
  • Modèle / numéro de série
    Serial number : USB1522023
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
  • Description du dispositif
    Toshiba DRAD-3000E FPD Wireless System || Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
  • 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