Events

Alerte De Sécurité sur Angiography equipment, risk class III: AXIOM ARTIS FC, registration 10234230075, lots / series: 10151, 10279, 10312, 10320, 10379, 10409, 10481, 10501, 10513, 10520, 10526, 10533./// AXIOM ARTIS FA , registration: 10234230093, lots / series: 25062; 25179; 25282; 25329; 25330; 25379; 25418; 25447; 25452. /// Angiography equipment models: AXIOM ARTIS dFA; AXIOM ARTIS dFC, registration 10234230096, batches / series: 35117; 35318; 35396; 35485; 35622; 35729; 35748; 35751; 35817; 35862; 35872; 35883; 35884; 35885; 35910; 35913; 35936; 35949; 50138./// Angiography equipment Artis models ARTIS ZEE CEILING, ARTIS ZEE FLOOR AND ARTIS ZEEGO, registry 1023420190, lots / series: 135297; 135329; 135758; 135785; 135816; 135825; 135835; 135848; 135869; 135941; 135969; 135980; 135984; 135991; 136056; 136060; 136067; 136068; 136098; 136115; 136119; 136136; 136144; 136199; 136213; 136214; 136215; 136276; 136282; 136283; 136284; 136285; 136288; 136301; 136320; 136355; 136363; 136369; 136373; 136419; 136421; 136424; 136425; 136440; 136443; 136457; 136492; 136580; 136908; 136918; 136926; 136933; 136936; 136944; 136947; 136977; 136995; 137020; 137026; 137033; 137042; 137045; 137074; 137083; 137088; 137089; 137094; 137098; 137099; 137100; 137102; 137105; 137120; 137143; 137158; 137159; 137160; 137161; 137162; 137164; 137182; 137246; 146646; 147531; 147551; 147582; 147600; 147602; 147617; 147619; 147637; 147650; 147706; 147708; 147744; 160143; 160343; 160360; 160415; 160457; 160467; 160836.

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.; SIEMENS AG..

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
    1653
  • Date
    2015-07-24
  • 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
    The holder informs that the problem involves a failure of the equipment having no influence on the treatment of patients.
  • Cause
    In case the table is near its maximum extension at the end of the head and there is a large amount of liquid on the table surface, the liquid may infiltrate the table through the existing fault and cause contamination of the electronic components. in the event of contamination, table movements may not occur.
  • Action
    The holding company will do the sealing in the failure of the top cover of the table column. This will ensure protection against ingress of liquids. The company will contact customers to schedule a visit to carry out corrective action.

Device

Angiography equipment, risk class III: AXIOM ARTIS FC, registration 10234230075, lots / series: 1...

Manufacturer

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