Events

Alerte De Sécurité sur Trade name: ARIA Technical name: ANVISA registration number: 10405410013 Hazard class: III Affected model: Not applicable Serial numbers affected: HIT7141; HIT7275; HIT7004; HIT4376M; HIT7271; HIT4376R1; HIT7175; HIT1827; HIT6999; HIT6238; HIT3172; HIT4459; HIT7248; HIT2388; HIT7084; HIT1741; HIT5549; HIT7541; HIT7576; HIT3931; HIT7140; HIT6154

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 Varian Medical Systems Brasil Ltda; Varian Medical Systems.

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
    2163
  • Date
    2016-09-13
  • 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
    Varian emphasizes the recommendation that users verify the values ​​of limitations and correlates with the nomenclature before creating a treatment plan. Varian Medical Systems is developing a technical fix for this problem. You will be contacted by a customer service representative when this fix is ​​available to schedule the installation on your system.
  • Cause
    An abnormality was identified in version 13.6 of the prescribe treatment regarding the storage and subsequent exposure of organ-at-risk (oar) dose-limitation values. the oar limit values ​​are displayed incorrectly on the prescribe treatment 13.6 workspace if the prescription has been created in versions 11.0, 13.0, or 13.5. the storage location of dosage and volume limiters has been changed in version 13.6. as a result of this problem, the display of the dosage-volume limiters will differ according to the version in which they were created and the version of the workspace in which they are displayed.
  • Action
    Field Action Code CP-26231 triggered under the responsibility of the company Varian Medical Systems Brazil Ltda. Company will make correction in the field.

Device

Trade name: ARIA Technical name: ANVISA registration number: 10405410013 Hazard class: III Affect...

Manufacturer

Varian Medical Systems Brasil Ltda; Varian Medical Systems