Events

Alerte De Sécurité sur ARTIS EQUIPMENT FOR ANGIOGRAPHY. Anvisa Registry No. 10234230158. Affected Series: 10501, 25418, 35318, 35748, 35817, 35872, 35913, 135329, 135758, 135816, 135825, 135835, 135848, 135941, 136115, 136199, 136282, 136301, 136320, 136369, 136373 , 136419, 136908, 160143, 160360, 160415, 160457 and 160467.

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.

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
    1202
  • Date
    2012-11-16
  • 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
    A certain component of the equipment - responsible for securing a pin to its original position - has not been adjusted correctly, which can cause the pin to come loose and leave some parts of the system loose, with the possibility of detaching. According to Siemens, the possibility of adverse events related to the operation of the system or the detachment and falling of parts, especially in the event of a collision with the equipment, can not be ruled out. The verification of the equipment has not yet been programmed by the company.
  • Cause
    No locking pin on the equipment, which can come out of position and let loose some parts of the system.
  • Action
    Siemens has already informed its customers of the problem and that a timeline for correction will be scheduled - the start date of the correction was not reported by the company.

Device

ARTIS EQUIPMENT FOR ANGIOGRAPHY. Anvisa Registry No. 10234230158. Affected Series: 10501, 25418, ...

Manufacturer

Siemens Ltda
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA