Events

Alerte De Sécurité sur Equipment for angiography Artis, models Artis zee ceiling; Artis zee floor; Artis zeego, registration 10234230190, hazard class III, lots / series: 135297; 135329; 135785; 135816; 135825; 135835; 135848; 135869; 135941; 135969; 135980; 135984; 135991; 136056; 136060; 136068; 136115; 136119; 136136; 136144; 136199; 136213; 136214; 136276; 136282; 136283; 136284; 136285; 136288; 136301; 136320; 136355; 136363; 136369; 136373; 136419; 136421; 136424; 136425; 136440; 136443; 136457; 136492; 136580; 146646; 160143; 160343; 160360; 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.; 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
    1652
  • Date
    2015-07-24
  • 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
    Considering the problem related to the locking of the system in the "Fluoro Bypass" mode, it is possible that there is no radiation release and no fluoroscopic images are acquired. The risk would be more related to the delay due to the system restart. In the second problem presented the risk are related to the possible unexpected movement of the equipment resulting in collision.
  • Cause
    Two problems with the system have been described by the company that holds the registry: the first would be in case of an error in the equipment and it is in the "bypass fluoro" mode, while the x-ray blocking function is active, it will not be the only way out of this function is to solve the root cause of the equipment being in the "bypass fluoro" mode or to restart the system. the other problem is related to the possible failure of the position sensor on the articulated base axis that is not detected by the system software. following activation of operator movement, the c-arm system may move unexpectedly faster than normal.
  • Action
    The company intends to continue to use the equipment until the company engineer's visit is made for field correction of the equipment. The field correction corresponds to the software update by installing two packages (11 and 12).

Device

Equipment for angiography Artis, models Artis zee ceiling; Artis zee floor; Artis zeego, registra...

Manufacturer

Siemens Ltda.; SIEMENS AG.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA