Events

Alerte De Sécurité sur ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Model Affected: Artis Q biplane, Artis Q ceiling, Artis Q floor, Artis Q.zen biplane, Artis Q.zen ceiling , Artis Q.zen floor, Artis zeego Serial numbers affected: 121125

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 Healthcare GmbH; Siemens Healthcare GmbH.

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
    2076
  • Date
    2017-01-06
  • 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
    The software problem can be corrected when you restart the system. It may take up to 8 minutes to restart the system. Normal emergency processes should be implemented in the event of a system failure. Ensure that these processes are prepared in advance until the update is applied. ### UPDATED ON 10/26/2017, the company submitted the completion report of the field action proving the sending of the security warning to the client with evidence from the science and all actions completed.
  • Cause
    The notification is intended to inform a corrective measure addressing two possible causes of a system defect and mutually independent. - in artis systems with a100plus or a100g generators, an attempt to resume operation after detecting a fault (such as a short-circuit in the x-ray tube, for example) may result in failure of a module in the high- voltage; - for bi-plane systems with the vd11b software version since april of this year, software problems in conjunction with graphics cards may, in rare cases, result in loss of presentation of images in the examination room.
  • Action
    Field Action Code AX001 / 16 / S & AX002 / 16 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA Company will make Field Correction.

Device

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 103...

Manufacturer

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