Events

Alerte De Sécurité sur COMPUTERIZED TOMOGRAPH AQUILION. MODELS: MULTI AQUILION (TSX-101A / 4); AQUILION 16 CFX EDITION (TSX-101A / 8); AQUILION 64 TSX-101A / E and AQUILION 32 TSX-101A / D. SERIAL NUMBERS: HCA0662228; HCA0692325; HCA0712498; HCA0722587; HCA0722590; HCA0732649; HCA0742673; HCA0752696; HCA0782874; HCA07X2929; HCA07X2933; HCA0813065; HCA0823119; HCA0833163; HCA0833172; HCA0863267; HCA0863268 and HCA0792893. Anvisa Registry: 10295030061.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par TOSHIBA MEDICAL DO BRASIL LTDA..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    952
  • Date
    2009-02-02
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to Toshiba Medical of Brazil Ltda., When there is a failure in the power supply, the immediate interruption of the x-ray generation occurs, and then the warning message "Abnormal XC Status" is shown to the user. In this way, according to the company, the failure in question does not produce damages to patients and users. If you need to contact the company to handle this case, the contact is as follows: Adriano Bordignom (Technology Manager), Tel. (11) 4134-0063. UTVIG / ANVISA is following up on this case.
  • Cause
    The power supply that controls the x-ray generating unit fails.
  • Action
    The holder of the product registration informed that he has already begun, on 05/01/2009, the process of correcting the problem - by changing the power supplies of the equipment under risk. To the users of the product it is recommended, if the equipment presents the warning message (ABNORMAL XC STATUS), contact the local technical assistance of Toshiba medical do Brasil Ltda (check the address and telephone number in the Manufacturer's description field.

Device

COMPUTERIZED TOMOGRAPH AQUILION. MODELS: MULTI AQUILION (TSX-101A / 4); AQUILION 16 CFX EDITION (...

Manufacturer

TOSHIBA MEDICAL DO BRASIL LTDA.
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    ANVSANVISA