Events

Alerte De Sécurité sur Product Name: ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Affected Model: Artis zeego, Artis zee biplane, Artis zee ceiling, Artis zee floor, Artis zee Multi-purpose Serial Numbers affected: 147551; 147708; 136918; 136933; 136947; 137020; 137026; 137042; 137045; 137074; 137105; 137164; 137379; 137411; 137658; 160457;

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
    2081
  • 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 for Megalix X-ray tube systems to perform focussed acquisition of images 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. Consider reinforcing these procedures until the upgrade has been made.
  • Cause
    For artis systems with software versions vc21c and vd11 and megalix cat + x-ray tubes, the semi-automatic focus switch may, in cases of defects in the "small" and "micro" foci (if present), not work as intended when pressing the pedal. this type of focus defect, which causes the failure of the semiautomatic focus switch, becomes more likely as the life of the x-ray tube increases. as a matter of clarity, systems with the vc21b software version do not are affected.
  • Action
    Field Action Code AX050 / 16 / S & AX051 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in the field.

Device

Product Name: ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registrati...

Manufacturer

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