Events

Alerte De Sécurité sur Technical Name: Equipment For Angiography ANVISA Registration Number: 10234120096 Hazard Class: III Affected Model: AXIOM Artis dFA, AXIOM Artis dFC Serial numbers affected: 35117; 35318; 35396; 35485; 35622; 35729; 35748; 35751; 35817; 35862; 35872; 35883; 35884; 35885; 35910; 5913; 35936; 35949; 50138

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 Healthcare Diagnósticos S.A.; 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
    2080
  • Date
    2016-12-06
  • 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
    It is possible, in 2-spot Megalix X-ray tube systems, to acquire images with large focus after manual selection of a corresponding organ program. In 3-spot Megalix X-ray systems, fluoroscopy is possible with the "small" or "micro" focus that is still intact through the manual selection of a corresponding fluoroscopy program. In addition, the acquisition of images with the big focus is possible. Standard emergency procedures must be in place in case of system failures. Siemens recommends enforcing these procedures until the upgrade has been made.
  • Cause
    For axiom artis systems with the vb35e software version and megalix x-ray tubes, the semi-automatic focus switch may, in the case of a special type of defect in the "small" and "micro" foci (if present), not work desired when pressing the pedal. the focus defect, which causes the semi-automatic focus switch to fail, becomes more likely as the life of the x-ray tube increases.
  • Action
    Field Action Code AX052 / 16 / S & AX053 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in the field.

Device

Technical Name: Equipment For Angiography ANVISA Registration Number: 10234120096 Hazard Class: I...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens AG.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA