Events

Alerte De Sécurité sur ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 80015490090 Hazard Class: III Affected Model: Artis Zee Ceiling, Artis Zee Floor, Artis Zee biplane, Artis Zeego, Artis Q biplane

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
    2209
  • Date
    2017-03-06
  • 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
    Users should notify and instruct their teams to be aware of this problem and if there are any questions regarding the addendum to the operating instructions, the company should be contacted.
  • Cause
    Siemens healthcare diagnostics informs that in the indicated artis systems a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear on the "small" and "micro" (if present) focus, an automatic focus is performed when the pedal is pressed several times. this special system function is not fully written in the currently available operating instructions. if a focus (small / micro) develops a fault, an alternative focus can be selected by pressing the pedal repeatedly. this allows the radiation to be generated again so that clinical treatment or diagnosis can proceed.
  • Action
    Field Action Code AX058 / 16 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA Company will update, correct or supplement the instructions for use.

Device

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 800...

Manufacturer

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