Events

Rappel de Device Recall Scanner, Computed Tomography, XRay

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
    62851
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2266-2012
  • Date de mise en oeuvre de l'événement
    2008-02-27
  • Date de publication de l'événement
    2012-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111873
  • 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
    x-ray tomography, computed system - Product Code JAK
  • Cause
    The systems all have a similar table control board. it has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. this is referred to as "free" mode in the operation manuals. if this error does occur it is possible that the patient could be scanned at an incorrect position.
  • Action
    Toshiba sent a "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to please avoid moving the table in the "Free" or manual mode as much as possible. If it is necessary to move the table in this manner please verify the table position prior to initiating the scan sequence. If it is noted that the position is not correct, exit the eXam plan and start a new one beginning with the scanoscopy. Please share this information with all users of the equipment and your clinical or biomedical engineering departments. Please find the attached customer reply form. The purpose of this form is for FDA tracking. Please take a moment to complete the form and fax it to the toll free number on the form.". The contact information for this recall is:"(800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.".

Device

Device Recall Scanner, Computed Tomography, XRay
  • Modèle / numéro de série
    Serial Number Range (last 4): (2665-3149), (2211-2237), (2057-2067), A3622041, A4582122 + (2690-3131), (2001-2171), (2001-2124), (2001-2255), (2001-3007), (2015-2061), (2001-2008).  The following Device Name/Model Number: Asteion Super 4 / TSX-021B Aquilion Super 4 / TSX-101A/7 Aquilion 8 / TSX-101A/F Aqui1ion 16/ TSX-101A/6 Aqui1ion 16/ TSX-101A/G Aquilion 32 / TSX-101A/D Aquilion 32 / TSX-101A/I Aquilion 64/TSX-101A/E Aquilion 64 / TSX-101AIH Aquilion 16 LB / TSX-201A AquilionONE / TSX-301A
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA ( Nationwide Distribution )
  • Description du dispositif
    Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. || This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
  • 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