Events

Alerte De Sécurité sur X-ray Generator, X-ray Generator Set (1) Model KXO-50R, (2) Model KXO-50F, Model KXO-80N

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 America Medical Systems Inc.

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
    676
  • Date
    2001-10-26
  • 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
    BRASIL-03.10.2002 / Letter from the company Toshiba Medical do Brasil Ltda, C-0340RX.2002, dated 27.03.2002, informs that the corrections are already being carried out with customers with the X-ray generator, model KXO 50- F. In addition, it covers not only the referenced model, but also the KXO-30R, KXO-30F, KXO-50N and KXO-80N models. -------------------------------------------------- ---------------------- On July 29, 2002, C-084RX.2002, the company Toshiba Medical do Brasil Ltda, announces the closure of the adequacy procedures of generators. Circuit Modification as instructed by Toshiba Corporation, Medical Sistems Division (Field Modification Instruction FMI - XR863) to conform to international standard CFR1020.31.
  • Cause
    The above x-ray controls / generators did not meet the 21 cfr 1020.31 (a) (2) requirements since uninterrupted exposure may occur as a result of tube bending. the manufacturer initiated a correction by letter dated july 19, 2001.
  • Action
    Verify receipt of letter and safety instructions from Toshiba America Medical Systems x-ray generator dated July 19, 2001. Identify all affected products in your inventory. Follow the instructions for safety use of the x-ray generators. For more information, contact your legal representative.

Device

X-ray Generator, X-ray Generator Set (1) Model KXO-50R, (2) Model KXO-50F, Model KXO-80N

Manufacturer

Toshiba America Medical Systems Inc
  • Source
    ANVSANVISA