Events

Alerte De Sécurité sur EQUIPMENT FOR ANGIOGRAPHY AXIOM ARTIS. ANVISA Registry: 10234230096 (Model FA). Affected Models: FA, FC, dFC, dTC, dFA and dTA.

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 Siemens 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
    961
  • Date
    2009-03-19
  • 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
    Siemens Ltda informed the ANVISA's Technovigilance Unit (UTVIG / ANVISA) that has already sent a communication letter to its customers, reporting the problem and advising on the necessary actions. The company also reported that it intends to update all AXIOM ARTIS systems that cause the problem reported in this alert, but has not yet reported the start date of the field action to be performed. #### Update on 04/20/2012: Accordingly with communication sent on 04/17/2012 by the company to UTVIG / ANVISA (file no. 0324770128, 04/19/12), the field action has already been finalized - software correction. The company reported that it performed the correction on ten equipments installed in Brazil.
  • Cause
    When a specific sequence of actions is performed, the generated images may be corrupted or contain non-clinical measures. the problem is related to the use of qva, qca or lva quantification software in combination with certain versions of axiom artis software.
  • Action
    Recommended actions for product users are as follows: When using the "Catheter Calibration" method as the basis for QVA, QCA or LVA quantification, the operator must not change the selected image after selecting the calibration method; that is, the calibration image should be selected before "Catheter Calibration" is started. Once "Calibration by Catheter" is selected, the image can no longer be changed. If your health care facility has affected equipment, contact the product registration holder to inform them and ask for the necessary steps to correct the equipment.

Device

EQUIPMENT FOR ANGIOGRAPHY AXIOM ARTIS. ANVISA Registry: 10234230096 (Model FA). Affected Models: ...

Manufacturer

Siemens Ltda.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA